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

Conditions

• Cancers With DNA Repair-Deficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 25, 2018

Status verified

Aug 2023

Primary completion

Dec 19, 2023

Completion

Dec 19, 2023

Study Design

Enrollment

102 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm E: Olaparib / Trabectedin
  Olaparib / Trabectedin
• Other: Arm C: Physician's choice
  Physician's choice

Primary Outcome Measure

Disease Control Rate [ Time Frame: At week 16 (after 5 cycles of study medication) ]