drugset / Trial / NCT02537561
Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
In this proposed study the investigators will combine gemcitabine and cisplatin with talazoparib to determine the recommended Phase 2 dose (RP2D) of this combination regimen. After determination of the RP2D patients with lung cancer whose tumors carry molecular alterations in DNA repair pathway genes will be enrolled to an expansion cohort to determine anti-tumor efficacy. Tissue samples of patients with confirmed partial response, complete response, and non-responders will be obtained for whole exome, and transcriptome sequencing to characterize the genetic alterations associated with response to therapy.
Timeline
- Start
- 2015-12
- Primary completion
- 2018-06
- Completion
- 2018-12
Outcome
Outcome not reported
Stopped: “The pharmaceutical company did not want to follow through with support for the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Talazoparib | Small molecule | — | Oral |