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

NCT03127215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-05-08

No results posted yet for this study

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

DRUG

Olaparib

Olaparib 150 mg tablet

DRUG

Physician's choice

treatment according to current guidelines

DRUG

Trabectedin

Trabectedin 1.1mg/m² infusional solution

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • PharmaMar

    collaborator INDUSTRY

  • German Cancer Research Center

    collaborator OTHER

  • National Center for Tumor Diseases, Heidelberg

    lead OTHER

Principal Investigators

  • Stefan Froehling, MD · NCT / DKFZ Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127215 on ClinicalTrials.gov