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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2023-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

NCT03690739

Recurrent Ovarian Carcinoma

TERMINATED PHASE3

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788

Borderline Ovarian Serous Tumor Micropapillary Serous Carcinoma Ovarian Serous Adenocarcinoma +3 more

COMPLETED PHASE2/PHASE3

PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer

NCT02571725

Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients

NCT02903004

Ovarian Neoplasms

COMPLETED PHASE3

Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

NCT02953457

BRCA1 Gene Mutation BRCA2 Gene Mutation Ovarian Serous Adenocarcinoma +3 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancers With DNA Repair-Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm E: Olaparib / Trabectedin

Olaparib / Trabectedin

Group Type EXPERIMENTAL

Olaparib

Intervention Type DRUG

Olaparib 150 mg tablet

Trabectedin

Intervention Type DRUG

Trabectedin 1.1mg/m² infusional solution

Arm C: Physician's choice

Physician's choice

Group Type OTHER

Physician's choice

Intervention Type DRUG

treatment according to current guidelines

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olaparib

Olaparib 150 mg tablet

Intervention Type DRUG

Physician's choice

treatment according to current guidelines

Intervention Type DRUG

Trabectedin

Trabectedin 1.1mg/m² infusional solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent
* Progressive locally advanced or metastatic malignancy
* Prior administration of standard treatment for primary and relapsed malignancy
* Eastern Cooperative Oncology Group Performance Status ≤1
* Patients with central venous access device in place (central venous catheter or porta-cath)
* Age ≥18 and ≤70 years
* Identification of defective DNA repair via HR
* Adequate bone marrow, renal, and hepatic function
* Hemoglobin ≥10 g/dl
* Neutrophil count ≥1,500/mm3
* Platelet count ≥100,000/µl
* Bilirubin ≤1.5 x upper limit of normal (ULN)
* ALT and AST ≤2.5 x ULN (≤5 x ULN in patients with hepatic tumor involvement)
* Alkaline phosphatase ≤2.5 x ULN
* PT-INR/PTT ≤1.5 x ULN
* Albumin ≥25 g/l
* Creatine kinase ≤2.5 x ULN
* Serum creatinine 1.5 mg/dl or creatinine clearance 51 ml/min

Exclusion Criteria

* Hematological malignancies and primary brain tumors.
* Concurrent treatment in another interventional clinical trial
* Prior treatment with PARP Inhibitors
* Patients with platinum-refractory disease, defined as progressive disease during or immediately after treatment with platinum based chemotherapy
* Persistent toxicity (\> Grade 2 according to CTCAE 5.0)
* Dementia or significant impairment of cognitive state
* History of HIV infection
* Clinical signs of active infection (\>Grade 2 according to CTCAE 4.03)
* History of viral hepatitis (HBV or HCV)
* Epilepsy requiring pharmacologic treatment
* Pregnancy
* Major surgical intervention 4 weeks prior to study inclusion
* Known hypersensitivity to any of the study drugs
* Hematologic malignancy
* QTc time prolongation \>500 ms or history of familial long-QT-syndrome
* Heart failure NYHA III/IV
* Severe obstructive or restrictive ventilation disorder
* Concomitant use of known strong CYP3A Inhibitors
* Concomitant use of known strong CYP3A inducers

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No