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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: National Center for Tumor Diseases, Heidelberg

Current Primary Outcome:

• Disease Control Rate [ Time Frame: At week 16 (after 5 cycles of study medication) ]
  Randomized, open-label, multicenter phase-II study comparing olaparib in combination with trabectedin versus physician's choice. Primary efficacy endpoint is the disease control rate after 5 cycles.
• Tumor response rate [ Time Frame: At week 16 (after 5 cycles of study medication) ]
  Defined as the sum of complete remission (CR) and partial remission (PR) according to RECIST version 1.1 after 5 cycles of study medication

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Overall survival [ Time Frame: Time from first administration of the IMP to time death from any cause until end of study (2.5 years) ]
  defined as the time from first administration of the IMP to time of death from any cause
• Incidence of Treatment-Emergent Adverse Events (toxicity, tolerability) [ Time Frame: Time from first administration of the IMP to subjects end of trial (approximately month 6) ]
  This endpoint includes all AEs, their severity, SAEs, the relation of AEs to the study treatment, dose modifications for toxicity and discontinuation of study treatment during the trial phase. Toxic effects will be graded according to the National Cancer Institute Common Toxicity Criteria
• Quality of life [ Time Frame: Before the first (week 0), at the third (week 8), and after the fifth treatment cycle (week 16) ]
  QoL will be assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases and demographics

Original Secondary Outcome: Same as current

Information By: National Center for Tumor Diseases, Heidelberg

Dates:
Date Received: March 31, 2017
Date Started: August 1, 2017
Date Completion: March 31, 2021
Last Updated: April 24, 2017
Last Verified: April 2017