NCT03127215

Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: National Center for Tumor Diseases, Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancers With DNA Repair-Deficiency

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib 150 mg tablet
DRUG	Physician's choice	treatment according to current guidelines
DRUG	Trabectedin	Trabectedin 1.1mg/m² infusional solution

Timeline

• Start date: 2018-10-25
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2017-04-25
• Last updated: 2024-05-08

Locations

9 sites across 1 country: Germany