Therapy Detail
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| Therapy Name | Nintedanib |
| Synonyms | |
| Therapy Description |
Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Nintedanib | Ofev | BIBF 1120|Vargatef|BIBF 1120 | FGFR Inhibitor (Pan) 26 PDGFR Inhibitor (Pan) 30 RET Inhibitor 53 VEGFR Inhibitor (Pan) 36 | Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KIT exon 11 del KIT V654A KIT D820A | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT D820A and V654A in culture (PMID: 38408285). | 38408285 |
| KIT Y823D | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT Y823D in culture (PMID: 35194937). | 35194937 |
| KIT D820G | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT D820G in culture (PMID: 35194937). | 35194937 |
| FGFR2 amp | colon cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (nintedanib) inhibited growth of colon cancer cells harboring FGFR2 amplification in culture (PMID: 22238366). | 22238366 |
| FGFR2 S252W | endometrial cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (Nintedanib) inhibited cell proliferation in endometrial cancer cells harboring FGFR2 S252W mutation in culture (PMID: 22238366). | 22238366 |
| KIT V559G | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT V559G in culture (PMID: 35194937). | 35194937 |
| KIT V559D | gastrointestinal stromal tumor | predicted - sensitive | Nintedanib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of patient-derived gastrointestinal stromal tumor cells harboring KIT V559D in culture (PMID: 35194937). | 35194937 |
| KIT D820E | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT D820E in culture (PMID: 35194937). | 35194937 |
| FGFR1 amp | estrogen-receptor positive breast cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (nintedanib) inhibited the growth of ER-positive breast cancer cells harboring FGFR1 amplification in culture (PMID: 22238366). | 22238366 |
| FGFR2 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR2 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| KIT exon 11 del KIT V654A | gastrointestinal stromal tumor | decreased response | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT V654A demonstrated reduced sensitivity to Ofev (nintedanib) compared to the parental cell line harboring a KIT exon 11 deletion in culture (PMID: 38408285). | 38408285 |
| KIT V654A | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT V654A in culture (PMID: 35194937). | 35194937 |
| KIT T670I | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT T670I in culture, and suppressed tumor growth in cell line xenograft models (PMID: 35194937). | 35194937 |
| KIT A829P | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT A829P in culture (PMID: 35194937). | 35194937 |
| FGFR2 N549K | endometrial cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (Nintedanib) did not inhibit growth of endometrial cancer cells harboring FGFR2 N549K in cell culture (PMID: 22238366). | 22238366 |
| KIT A502_Y503dup | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring KIT A502_Y503dup in culture (PMID: 38408285). | 38408285 |
| KIT V559D KIT V654A | Advanced Solid Tumor | predicted - sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing KIT V559D and V654A demonstrated decreased proliferation in response to Ofev (nintedanib) in culture, but were less sensitive to treatment compared to cells expressing either KIT V559D or KIT V654A alone (PMID: 35194937). | 35194937 |
| KIT exon 11 del KIT D820Y | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT D820Y in culture (PMID: 38408285). | 38408285 |
| KIT V559D KIT T670I | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT V559D and T670I in culture (PMID: 35194937). | 35194937 |
| KIT V559D | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT V559D in culture (PMID: 35194937). | 35194937 |
| KIT D820Y | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT D820Y in culture (PMID: 35194937). | 35194937 |
| KIT L576P | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited Kit autophosphorylation and proliferation of transformed cells expressing KIT L576P in culture (PMID: 35194937). | 35194937 |
| KIT V560_Y578del KIT T670I | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ofev (nintedanib) decreased Kit phosphorylation and downstream signaling, induced cell-cycle arrest and apoptosis, and inhibited proliferation of a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del and T670I in culture, and suppressed tumor growth in cell line xenograft models (PMID: 35194937). | 35194937 |
| FGFR3 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| KIT exon 11 del KIT V654A KIT A829P | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT A829P and V654A in culture (PMID: 38408285). | 38408285 |
| KIT exon 11 del KIT T670I | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT T670I in culture (PMID: 38408285). | 38408285 |
| KIT T670E | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT T670E in culture (PMID: 35194937). | 35194937 |
| KIT exon 11 del KIT D820A | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT D820A in culture (PMID: 38408285). | 38408285 |
| FGFR1 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR1 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| KIT D816E | Advanced Solid Tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited proliferation of transformed cells expressing KIT D816E in culture (PMID: 35194937). | 35194937 |
| KIT V560_Y578del | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ofev (nintedanib) decreased Kit phosphorylation and downstream signaling, induced cell-cycle arrest and apoptosis, and inhibited proliferation of a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del in culture, and suppressed tumor growth in cell line xenograft models (PMID: 35194937). | 35194937 |
| FGFR3 Y375C | urinary bladder cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, bladder cancer cells harboring FGFR3 Y375C were resistant to growth inhibition by Ofev (Nintedanib) in culture (PMID: 22238366). | 22238366 |
| KIT K642E | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ofev (nintedanib) decreased Kit phosphorylation and downstream signaling, induced cell-cycle arrest and apoptosis, and inhibited proliferation of a gastrointestinal stromal tumor cell line and patient-derived cells harboring KIT K642E in culture, and suppressed tumor growth in cell line xenograft models (PMID: 35194937). | 35194937 |
| FGFR3 S249C | urinary bladder cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, bladder cancer cells harboring FGFR3 S249C were resistant to Ofev (Nintedanib) induced inhibition of cell proliferation in culture (PMID: 22238366). | 22238366 |
| KIT exon 11 del | gastrointestinal stromal tumor | sensitive | Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, Ofev (nintedanib) inhibited viability of a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion in culture (PMID: 38408285). | 38408285 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01948141 | Phase II | Nintedanib | Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens | Completed | USA | 0 |
| NCT02863055 | Phase II | Nintedanib | Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO) | Active, not recruiting | ITA | GBR | BEL | 0 |
| NCT02234596 | Phase II | Nintedanib | Nintedanib in Patients With Advanced Esophagogastric Cancer | Completed | USA | 0 |
| NCT02496585 | Phase II | Nintedanib Prednisone | Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis | Completed | USA | 0 |
| NCT02780700 | Phase II | Capecitabine + Nintedanib Nintedanib | Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] | Terminated | USA | 0 |
| NCT02568449 | Phase II | Nintedanib | Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent | Completed | USA | 0 |
| NCT02902484 | Phase Ib/II | Gemcitabine + Nab-paclitaxel + Nintedanib Nintedanib | Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer | Terminated | USA | 0 |
| NCT01907100 | Phase III | Cisplatin + Pemetrexed Disodium Nintedanib | Nintedanib (BIBF 1120) in Mesothelioma | Terminated | USA | TUR | SWE | POL | NOR | NLD | ITA | ISR | HRV | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | ARG | 7 |
| NCT02231164 | Phase III | Docetaxel Nintedanib | LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research | Terminated | USA | 2 |
| NCT02149108 | Phase III | Nintedanib | Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal Cancer | Completed | USA | TUR | SWE | POL | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | ARG | 7 |
| NCT02665143 | Phase Ib/II | Cytarabine + Idarubicin Nintedanib | A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT02299141 | Phase I | Nintedanib | Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
| NCT02452463 | Phase II | Nintedanib | Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy | Terminated | USA | 0 |
| NCT02399215 | Phase II | Nintedanib | Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors | Completed | USA | 0 |
| NCT03287947 | Phase II | Nintedanib | LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma | Terminated | USA | 0 |
| NCT01669798 | Phase II | Nintedanib | BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer | Completed | USA | 0 |
| NCT02152059 | Phase II | Nintedanib | A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy | Withdrawn | CAN | 0 |
| NCT02389764 | Phase II | Nintedanib | Nintedanib For HER2-negative Metastatic Inflammatory Breast Cancer (MIBC) | Terminated | USA | 0 |
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