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| Therapy Name | Palbociclib |
| Synonyms | |
| Therapy Description |
Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CDKN2A pos RB1 inact mut | glioblastoma | resistant | Palbociclib | Preclinical - Patient cell culture | Actionable | In a preclinical study, patient-derived glioblastoma cells harboring RB1 truncation mutation and expressing Cdkn2a were resistant to Ibrance (palbociclib) in culture (PMID: 22711607). | 22711607 |
| CDKN2A inact mut | malignant spiradenoma | predicted - sensitive | Palbociclib | Case Reports/Case Series | Actionable | In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment resulted in decreased size of the pulmonary nodules and right hilar mass, decreased pleural thickening and mediastinal lymphadenopathy, and an overall response in a patient with metastatic spiradenocarcinoma harboring a CDKN2A nonsense mutation (PMID: 38899982; NCT02693535). | 38899982 |
| BRAF mut RB1 loss | melanoma | decreased response | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a melanoma cell line harboring a BRAF mutation and loss of RB1 demonstrated a decreased response to Ibrance (palbociclib) treatment in culture when compared to treatment of melanoma cell lines wild-type for BRAF (PMID: 27488531). | 27488531 |
| CDKN2A loss | melanoma | resistant | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a melanoma cell line deficient for CDKN2A demonstrated resistance to treatment with Ibrance (palbociclib) in culture (PMID: 27488531). | 27488531 |
| RB1 positive | glioblastoma | predicted - sensitive | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited proliferation of RB1-proficient glioblastoma cell lines in culture and inhibited tumor growth in intracranial cell line xenograft models (PMID: 20354191). | 20354191 |
| CDKN2A loss | biliary tract cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), patients with biliary cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.3 weeks and an overall survival of 11.1 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535). | detail... |
| NRAS Q61L NRAS mut | melanoma | decreased response | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, NRAS-mutant melanoma cells expressing NRAS Q61L demonstrated a decreased response to treatment with Ibrance (palbociclib) in culture when compared to control (PMID: 30819666). | 30819666 |
| CDKN2A del | high grade glioma | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited viability in glioma cell lines harboring IDH1 R132H and deletion of CDKN2A in culture (PMID: 38718141). | 38718141 |
| CDKN2A mutant | biliary tract cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), patients with biliary cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.3 weeks and an overall survival of 11.1 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535). | detail... |
| PTEN loss | breast cancer | decreased response | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, two PTEN-deficient breast cancer cell lines demonstrated a decreased response to treatment with Ibrance (palbociclib) compared to control cells in culture (PMID: 31594766). | 31594766 |
| CDKN2A loss | renal cell carcinoma | sensitive | Palbociclib | Preclinical | Actionable | In a preclinical study, renal cell carcinoma cell lines with CDKN2A loss were sensitive to Palbociclib (PD-0332991) (PMID: 23898052). | 23898052 |
| BRAF wild-type | melanoma | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, BRAF wild-type melanoma cells demonstrated decreased cell viability when treated with Ibrance (palbociclib) in culture (PMID: 27488531). | 27488531 |
| FLT3 exon 14 ins | hematologic cancer | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3 ITD were sensitive to treatment with Ibrance (palbociclib), demonstrating inhibition of cell growth in culture (PMID: 30544932). | 30544932 |
| FLT3 D835Y | acute myeloid leukemia | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, patient-derived acute myeloid leukemia cells harboring FLT3 D835Y were sensitive to treatment with Ibrance (palbociclib) in culture, demonstrating reduced cell viability and colony formation (PMID: 30544932). | 30544932 |
| PIK3CA H1047R | oral squamous cell carcinoma | resistant | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, oral squamous cell carcinoma cells expressing PIK3CA H1047R demonstrated resistance to Ibrance (palbociclib) treatment in culture (PMID: 31516747). | 31516747 |
| BRAF V600E | melanoma | no benefit | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with Ibrance (palbociclib) in a melanoma cell line xenograft model harboring BRAF V600E resulted in no benefit, demonstrating low but continuous growth (PMID: 27488531). | 27488531 |
| CDKN2A del | glioblastoma | sensitive | Palbociclib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited proliferation of patient-derived glioblastoma cells harboring homozygous deletion of CDKN2A in culture and prolonged survival in patient-derived xenograft models (PMID: 22711607). | 22711607 |
| RB1 loss | Advanced Solid Tumor | no benefit | Palbociclib | Preclinical | Actionable | In preclinical studies, the CDK4/6 inhibitor, Ibrance (palbociclib), was not effective in a variety of solid tumors with Rb1-deficiency (PMID: 26649278). | 26649278 |
| CDKN2A mutant | pancreatic cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), patients with pancreatic cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.2 weeks and an overall survival of 12.4 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535). | detail... |
| NRAS Q61K NRAS mut | melanoma | decreased response | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, NRAS-mutant melanoma cells expressing NRAS Q61K demonstrated a decreased response to treatment with Ibrance (palbociclib) in culture compared to control (PMID: 30819666). | 30819666 |
| FLT3 exon 14 ins FLT3 D835Y | hematologic cancer | no benefit | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells co-expressing FLT3 ITD and FLT3 D835Y did not respond to treatment with Ibrance (palbociclib) in culture (PMID: 30544932). | 30544932 |
| CDKN2A negative | lung non-small cell carcinoma | predicted - sensitive | Palbociclib | Phase II | Actionable | In a Phase II trial, Ibrance (palbociclib) treatment resulted in no objective response (0/16) and stable disease in 50% (8/16) of patients with advanced Cdkn2a-null (by IHC) non-small cell lung cancer, with a median overall survival (mOS) of 5.1 months for all patients and a mOS of 16.6 months in patients achieved stable disease (PMID: 30647837; NCT01291017). | 30647837 |
| NRAS wild-type | melanoma | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, NRAS wild-type melanoma cells demonstrated decreased cell viability when treated with Ibrance (palbociclib) in culture (PMID: 27488531). | 27488531 |
| RB1 positive | prostate cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial, addition of Ibrance (palbociclib) to androgen deprivation therapy (ADT) did not improve the rate of PSA less or equal to 4 ng/ml at 28 weeks (80%, 32/40 vs 80%, 16/20, p=0.87), PSA undetectable rate at 28 weeks (43% vs 50%, p=0.5), radiographic response rate (89% vs 89%), or 12-month biochemical progression-free survival (74% vs 69%, p=0.72) in patients with metastatic hormone-sensitive prostate cancer expressing Rb1 as confirmed by IHC (PMID: 33727260; NCT02059213). | 33727260 |
| CDKN2A loss | lung squamous cell carcinoma | predicted - sensitive | Palbociclib | Clinical Study - Cohort | Actionable | In a Phase II trial (NLMT), Ibrance (palbociclib) treatment resulted in an observed objective response rate (ORR) of 0% (0/19), durable clinical benefit rate (DCBR) of 22% (4/18), and medial progression-free survival (PFS) of 4.2 months in patients with lung squamous cell carcinoma harboring CDKN2A loss, with Bayesian estimated OR and DCBR of 3% and 24%, respectively, and Bayesian predictive probability of success for PFS >0.99 (PMID: 32669708, NCT02664935). | 32669708 |
| SMARCB1 negative | rhabdoid cancer | sensitive | Palbociclib | Preclinical | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited growth of SMARCB1-negative malignant rhabdoid tumor cell lines in culture, and sensitivity was associated with low levels of p16 expression (PMID: 21871868). | 21871868 |
| NRAS mutant | melanoma | conflicting | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ibrance (palbociclib) treatment resulted in stable tumor growth in melanoma cell line xenograft models harboring an NRAS mutation, however, growth later ensued and thus, demonstrated a lack of benefit (PMID: 27488531). | 27488531 |
| NRAS mutant | melanoma | conflicting | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, NRAS-mutant melanoma cell lines were sensitive to treatment with Ibrance (palbociclib) in culture, demonstrating decreased cell viability, colony formation, and pathway activity, and increased cell cycle arrest (PMID: 30819666). | 30819666 |
| CDKN2A inact mut | lung non-small cell carcinoma | predicted - sensitive | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment resulted in a disease control rate of 31% with 1 partial response and 6 with stable disease at 16 weeks in patients with advanced or metastatic non-small cell lung cancer harboring CDKN2A loss or mutations (n=29), with a median progression-free survival of 8.1 weeks and a median overall survival of 21.6 weeks (PMID: 35050752; NCT02693535). | 35050752 |
| CDKN2A over exp SMARCB1 neg | rhabdoid cancer | decreased response | Palbociclib | Preclinical | Actionable | In a preclinical study, CDKN2A (p16) over expression was associated with decreased sensitivity to Ibrance (palbociclib) in a SMARCB1-negative malignant rhabdoid tumor cell line in culture (PMID: 21871868). | 21871868 |
| PIK3CA H1047L | oral squamous cell carcinoma | decreased response | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with Ibrance (palbociclib) resulted in sustained tumor growth, but increasing tumor volume over time with treatment in oral squamous cell carcinoma cell line xenograft models harboring PIK3CA H1047L (PMID: 31516747). | 31516747 |
| CDKN2A loss | lung non-small cell carcinoma | predicted - sensitive | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment resulted in a disease control rate of 31% with 1 partial response and 6 with stable disease at 16 weeks in patients with advanced or metastatic non-small cell lung cancer harboring CDKN2A loss or mutations (n=29), with a median progression-free survival of 8.1 weeks and a median overall survival of 21.6 weeks (PMID: 35050752; NCT02693535). | 35050752 |
| CDKN2A loss | lung non-small cell carcinoma | predicted - sensitive | Palbociclib | Phase II | Actionable | In a Phase II trial, treatment with Ibrance (palbociclib) resulted in stable disease in 50% (8/16) of non-small cell lung cancer patients with CDKN2A loss (J Clin Oncol 32:5s, 2014 (suppl; abstr 8077)). | detail... |
| FLT3 act mut | acute myeloid leukemia | sensitive | Palbociclib | Preclinical | Actionable | In a preclinical study, Ibrance (palbociclib) blocked growth, induced apoptosis, and inhibited STAT activation in human FLT3-ITD positive human acute myeloid leukemia cells in culture (PMID: 27099147). | 27099147 |
| FLT3 wild-type | acute myeloid leukemia | sensitive | Palbociclib | Preclinical | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited growth of human FLT3 wild-type human leukemia cells in culture (PMID: 27099147). | 27099147 |
| RB1 loss | estrogen-receptor positive breast cancer | resistant | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, RB1 loss was associated with acquired resistance to Ibrance (palbociclib) in an estrogen-receptor positive breast cancer cell line in culture (PMID: 27020857). | 27020857 |
| RB1 mutant | estrogen-receptor positive breast cancer | predicted - resistant | Palbociclib | Phase III | Actionable | In a Phase III trial (PALOMA-3), acquired RB1 mutations were identified in patents with ER-positive, ERBB2 (HER2)-negative breast cancer at the end of treatment in the Faslodex (fulvestrant) plus Ibrance (palbociclib) but not the Faslodex (fulvestrant) plus placebo arm, suggesting a role in conferring resistance to Ibrance (palbociclib) (PMID: 30206110; NCT01942135). | 30206110 |
| RB1 inact mut | glioblastoma | resistant | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ibrance (palbociclib) failed to inhibit growth of RB1-deficient glioblastoma cell lines in culture and in intracranial cell line xenograft models (PMID: 20354191). | 20354191 |
| CDKN2A del | gastrointestinal stromal tumor | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial, Ibrance (palbociclib) treatment did not demonstrated clinical efficacy in heavily pre-treated gastrointestinal stromal tumor patients harboring CDKN2A homozygous or heterozygous deletion, with 86.4% (19/22) of patients demonstrated progressive disease at 4 months (PMID: 30979737; NCT01907607). | 30979737 |
| CDKN2A R80* | stomach carcinoma | sensitive | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, a gastric carcinoma cell line harboring CDKN2A R80* was sensitive to Ibrance (palbociclib) both in culture and in cell line xenograft models (PMID: 26380006, PMID: 20952405). | 26380006 20952405 |
| CDKN2A A17fs | lung adenocarcinoma | predicted - sensitive | Palbociclib | Case Reports/Case Series | Actionable | In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment resulted in a partial response in a patient with lung adenocarcinoma harboring CDKN2A A17fs (PMID: 35050752; NCT02693535). | 35050752 |
| CDKN2A loss | lung adenocarcinoma | predicted - sensitive | Palbociclib | Clinical Study - Cohort | Actionable | In a Phase II trial (NLMT), Ibrance (palbociclib) treatment resulted in an observed objective response rate (ORR) of 4% (1/27), durable clinical benefit rate (DCBR) of 27.5% (8/29), and medial progression-free survival (PFS) of 3.3 months in patients with lung adenocarcinoma harboring CDKN2A loss, with Bayesian estimated OR and DCBR of 6% and 29%, respectively, and Bayesian posterior probability for PFS of 0.69 (PMID: 32669708, NCT02664935). | 32669708 |
| SMARCA4 inact mut | Advanced Solid Tumor | no benefit | Palbociclib | Clinical Study | Actionable | In a combined analysis of 2 clinical trials (DRUP, MoST), Ibrance (palbociclib) or Kisqali (ribociclib) monotherapy had limited efficacy and resulted in no objective responses, a 15% clinical benefit rate at 16 weeks, median progression-free survival of 4 mo, and median overall survival of 5 mo in previously treated advanced solid tumor patients (n=112) with inactivating SMARCA4 mutations, CDKN2A loss, or CDK4, CDK6, CCND1, CCND2, or CCND3 amplification (PMID: 37424386; NCT02925234, ACTRN12616000931471). | 37424386 |
| CDKN2A loss | Advanced Solid Tumor | no benefit | Palbociclib | Clinical Study | Actionable | In a combined analysis of 2 clinical trials (DRUP, MoST), Ibrance (palbociclib) or Kisqali (ribociclib) monotherapy had limited efficacy and resulted in no objective responses, a 15% clinical benefit rate at 16 weeks, median progression-free survival of 4 mo, and median overall survival of 5 mo in previously treated advanced solid tumor patients (n=112) with CDKN2A loss, CDK4, CDK6, CCND1, CCND2, or CCND3 amplification, or inactivating SMARCA4 mutations (PMID: 37424386; NCT02925234, ACTRN12616000931471). | 37424386 |
| CDKN2A H142R | B-cell acute lymphoblastic leukemia | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, Ibrance (palbociclib) treatment inhibited viability of a B-cell acute lymphoblastic leukemia cell line expressing CDKN2A H142R in culture (PMID: 34369425). | 34369425 |
| CDKN2A loss | chordoma | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited expression of phosphorylated Rb and growth of chordoma cell lines with CDKN2A loss and loss of p16 protein expression in culture (PMID: 26183925). | 26183925 |
| FLT3 D835Y | hematologic cancer | sensitive | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, transformed cells expressing FLT3 D835Y were sensitive to treatment with Ibrance (palbociclib), demonstrating reduced cell viability in culture and tumor growth inhibition in cell line xenograft models (PMID: 30544932). | 30544932 |
| CDKN2A loss | pancreatic cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial (TAPUR), patients with pancreatic cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.2 weeks and an overall survival of 12.4 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535). | detail... |
| NRAS mut PIK3CA E545K | melanoma | predicted - resistant | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, two of two NRAS-mutant melanoma cell lines expressing PIK3CA E545K demonstrated resistance to treatment with Ibrance (palbociclib) in culture (PMID: 30819666). | 30819666 |
| RB1 positive | medulloblastoma | sensitive | Palbociclib | Preclinical - Pdx | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited Rb1 phosphorylation in tumor tissues and improved survival in patient-derived intracranial xenograft models of medulloblastoma (PMID: 27012813). | 27012813 |
| PTEN loss RB1 loss | triple-receptor negative breast cancer | resistant | Palbociclib | Preclinical | Actionable | In a preclinical study, a triple-receptor negative breast cancer line harboring PTEN and RB1 loss was resistant to Ibrance (palbociclib) induced growth inhibition in culture (PMID: 27020857). | 27020857 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02626507 | Phase I | Palbociclib Gedatolisib Goserelin Fulvestrant | Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer | Unknown status | USA | 0 |
| NCT03158389 | Phase Ib/II | Vismodegib Alectinib Idasanutlin Temsirolimus Atezolizumab Palbociclib APG101 | NCT Neuro Master Match - N²M² (NOA-20) (N²M²) | Completed | DEU | 0 |
| NCT05067530 | Phase II | Paclitaxel Palbociclib Carboplatin Carboplatin + Paclitaxel Paclitaxel + Palbociclib | Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study (CAREGIVER) | Not yet recruiting | POL | 0 |
| NCT04591431 | Phase II | Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) | Active, not recruiting | ITA | 0 |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) | Recruiting | USA | 0 |
| NCT04585724 | Phase I | Abemaciclib Palbociclib Ribociclib | Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases | Withdrawn | 0 | |
| NCT03242382 | Phase II | Palbociclib | Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. (PalboSarc) | Recruiting | ESP | 0 |
| NCT03147287 | Phase II | Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant | Palbociclib After CDK and Endocrine Therapy (PACE) | Active, not recruiting | USA | 0 |
| NCT02513394 | Phase III | Palbociclib | PALbociclib CoLlaborative Adjuvant Study (PALLAS) | Active, not recruiting | USA | SWE | POL | NLD | ITA | ISR | IRL | HUN | GBR | ESP | DEU | CHE | CAN | BEL | AUT | AUS | 5 |
| NCT05238831 | Phase II | Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole | SMMART Adaptive Clinical Treatment (ACT) Trial | Withdrawn | 0 | |
| NCT03088059 | Phase II | Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil | Biomarker-based Study in R/M SCCHN (UPSTREAM) | Active, not recruiting | ITA | GBR | FRA | ESP | BEL | 0 |
| NCT02059213 | Phase II | Goserelin Palbociclib Bicalutamide Leuprolide | A Phase II Study of Androgen Deprivation Therapy With or Without PD 0332991 in RB-Positive Metastatic Prostate Cancer | Completed | USA | 0 |
| NCT06380751 | Phase III | Ribociclib Fulvestrant Camizestrant + Saruparib Anastrozole Camizestrant + Ribociclib Letrozole Camizestrant + Palbociclib Abemaciclib + Camizestrant Exemestane Abemaciclib Palbociclib | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (EvoPAR-BR01) | Recruiting | USA | TUR | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 11 |
| NCT03526250 | Phase II | Palbociclib | Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) | Completed | USA | 1 |
| NCT03123744 | Phase II | Palbociclib | Histology-Independent Study of Palbociclib in Patients With Advanced Cancer | Withdrawn | USA | 0 |
| NCT05725200 | Phase II | Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) | Recruiting | NOR | 0 |
| NCT02785939 | Phase II | Palbociclib | Lung-MAP: Palbociclib as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches | Completed | USA | 0 |
| NCT02040857 | Phase II | Exemestane Palbociclib Tamoxifen Letrozole Anastrozole | A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer | Completed | USA | 0 |
| NCT03609047 | Phase II | Palbociclib Cyclophosphamide + Epirubicin Paclitaxel Cyclophosphamide + Docetaxel Cyclophosphamide + Doxorubicin | Adjuvant Palbociclib in Elderly Patients With Breast Cancer (Appalaches) | Active, not recruiting | POL | ITA | GBR | FRA | ESP | DEU | BEL | 2 |
| NCT01723774 | Phase II | Palbociclib Anastrozole Goserelin | PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer | Active, not recruiting | USA | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Terminated | USA | 0 |
| NCT02896335 | Phase II | Palbociclib | Palbociclib In Progressive Brain Metastases | Recruiting | USA | 0 |
| NCT02296801 | Phase II | Palbociclib Letrozole | A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer | Completed | USA | GBR | CAN | 0 |
| NCT01864746 | Phase III | Palbociclib | A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery (PENELOPE-B) | Completed | USA | IRL | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 2 |
| NCT03170206 | Phase Ib/II | Palbociclib Binimetinib Binimetinib + Palbociclib | Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
| NCT03784014 | Phase III | Ceritinib Dabrafenib + Trametinib Capmatinib Durvalumab + Olaparib Nilotinib Futibatinib Trametinib Palbociclib Glasdegib Lapatinib | Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC) | Active, not recruiting | FRA | 0 |
| NCT03870919 | FDA approved | Palbociclib | Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients (PALATINE) | Active, not recruiting | FRA | 0 |
| NCT05069038 | Phase II | Palbociclib | Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy | Recruiting | USA | 0 |
| NCT02334527 | Phase II | Palbociclib | Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer (UC) After Failure of First-Line Chemotherapy | Terminated | USA | 0 |
| NCT01536743 | Phase II | Palbociclib | A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression | Completed | USA | 0 |
| NCT03439735 | Phase II | Palbociclib Fulvestrant + Palbociclib | Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC | Recruiting | USA | 0 |
| NCT01356628 | Phase II | Palbociclib | A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer | Completed | USA | 0 |
| NCT02255461 | Phase I | Palbociclib | Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors | Terminated | USA | 0 |
| NCT03110744 | Phase II | Palbociclib | CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma (NCT-PMO-1601) | Completed | DEU | 0 |
| NCT02905318 | Phase II | Palbociclib | Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer | Active, not recruiting | CAN | 0 |
| NCT04801966 | Phase 0 | Palbociclib Alpelisib Atezolizumab Vemurafenib Ribociclib Talazoparib Cobimetinib Trametinib Abemaciclib Dabrafenib Nivolumab Binimetinib Pembrolizumab Encorafenib | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study (TAILOR) | Terminated | AUS | 0 |
| NCT01320592 | Phase I | Palbociclib Paclitaxel | PD0332991/Paclitaxel in Advanced Breast Cancer | Completed | USA | 0 |
| NCT03535506 | Phase II | Palbociclib | Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (WI223281) | Terminated | USA | 0 |
| NCT05694871 | Phase II | Cemiplimab + Palbociclib Palbociclib | Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma | Active, not recruiting | USA | 0 |
| NCT06044623 | Phase III | Exemestane Abemaciclib Palbociclib Ribociclib Letrozole Anastrozole Fulvestrant | Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients (IMPORTANT) | Recruiting | SWE | NOR | ITA | GRC | FIN | ESP | 0 |
| NCT02764541 | Phase II | Palbociclib Palbociclib + Tamoxifen Letrozole Tamoxifen | Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) | Active, not recruiting | USA | 0 |
| NCT05432518 | Phase I | Olaparib Palbociclib Afatinib Everolimus Dasatinib | GBM Personalized Trial | Recruiting | CAN | 0 |
| NCT02499120 | Phase II | Palbociclib Cetuximab | Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer | Completed | USA | SVK | ROU | POL | ITA | HUN | ESP | CZE | 7 |
| NCT04318223 | Phase II | Palbociclib | Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy | Unknown status | ITA | 0 |
| NCT05949424 | FDA approved | Lenvatinib Olaparib Pazopanib Palbociclib Sunitinib | OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults (OPTI-DOSE) | Not yet recruiting | NLD | 0 |
| NCT02947685 | Phase III | Fulvestrant Pertuzumab Letrozole Anastrozole Exemestane Palbociclib Trastuzumab | Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) | Active, not recruiting | USA | NZL | ITA | FRA | ESP | DEU | AUS | 1 |
| NCT02030483 | Phase I | Palbociclib Dexamethasone Lenalidomide | Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma | Terminated | USA | 0 |
| NCT02630693 | Phase II | Palbociclib Fulvestrant Tamoxifen | Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer | Completed | CAN | 0 |
| NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) | Recruiting | CAN | 0 |
| NCT02774681 | Phase II | Trastuzumab Palbociclib | Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis | Terminated | USA | 0 |
| NCT02154490 | Phase II | Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab Fexagratinib Taselisib Durvalumab + Tremelimumab Erlotinib + Rilotumumab Talazoparib Erlotinib | Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer | Completed | USA | CAN | 0 |
| NCT03132454 | Phase I | Decitabine + Palbociclib Dexamethasone + Palbociclib Palbociclib Palbociclib + Sorafenib | Study of Palbociclib Alone and in Combination in Patients With Relapsed and Refractory (R/R) Leukemias | Recruiting | USA | 0 |
| NCT01037790 | Phase II | Palbociclib | PHASE II TRIAL OF THE CYCLIN-DEPEDENT KINASE INHIBITOR PD 0332991 IN PATIENTS WITH CANCER | Completed | USA | 0 |
| NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | CAN | AUS | 1 |
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