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Therapy Name | GDC-0575 + Gemcitabine |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
GDC-0575 | ARRY-575|RG7741 | CHK1 Inhibitor 18 | GDC-0575 selectively inhibits CHK1, which potentially results in increased response to chemotherapeutic agents (PMID: 29162833, PMID: 29788155). | |
Gemcitabine | Gemzar | Difluorodeoxycytidine Hydrochlorothiazide|LY-188011 | Chemotherapy - Antimetabolite 14 | Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TP53 mutant | sarcoma | predicted - sensitive | GDC-0575 + Gemcitabine | Phase I | Actionable | In a Phase I trial, GDC-0575 and Gemzar (gemcitabine) combination treatment resulted in a prolonged tumor response in 2 soft tissue sarcoma patients harboring TP53 mutations, and no response in a patient with TP53 wild-type tumor (PMID: 29409053; NCT01564251). | 29409053 |
TP53 mutant | fibrous histiocytoma | predicted - sensitive | GDC-0575 + Gemcitabine | Preclinical - Pdx | Actionable | In a preclinical study, GDC-0575 and Gemzar (gemcitabine) combination treatment inhibited tumor growth, prolonged progression-free survival in patient-derived xenogrft (PDX) models of undifferentiated pleomorphic sarcoma (fibrous histiocytoma) (PMID: 29409053). | 29409053 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01564251 | Phase I | GDC-0575 + Gemcitabine GDC-0575 | A Study of GDC-0575 Alone And in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma | Completed | USA | FRA | 0 |