drugset / Trial / NCT03127215
Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors
Phase 2
Completed
102 enrolled
National Center for Tumor Diseases, Heidelberg
AstraZeneca · collabGerman Cancer Research Center · collabPharmaMar · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients with locally advanced/metastatic solid tumors that failed standard treatment and whose molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The primary objective is to show superior disease control rate in patients with HRR-deficient tumors treated with olaparib and trabectedin compared to treatment according to current guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of HRR-deficient tumors across entities can be exploited for therapeutic benefit.
Timeline
- Start
- 2018-10-25
- Primary completion
- 2023-12-19
- Completion
- 2023-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 150 mg | — |
| Subject | Trabectedin | Small molecule | 1.1 mg/m2 | — |