Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors (NCT-PMO-1603)
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ClinicalTrials.gov Identifier: NCT03127215 |
Recruitment Status : Unknown
Verified November 2018 by National Center for Tumor Diseases, Heidelberg.
Recruitment status was: Recruiting
First Posted : April 25, 2017
Last Update Posted : November 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancers With DNA Repair-Deficiency | Drug: Olaparib Drug: Physician's choice Drug: Trabectedin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | randomized |
Masking: | None (Open Label) |
Masking Description: | open label |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 25, 2018 |
Estimated Primary Completion Date : | March 31, 2020 |
Estimated Study Completion Date : | March 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm E: Olaparib / Trabectedin
Olaparib / Trabectedin
|
Drug: Olaparib
Olaparib 150 mg tablet Drug: Trabectedin Trabectedin 1.1mg/m² infusional solution |
Arm C: Physician's choice
Physician's choice
|
Drug: Physician's choice
treatment according to current guidelines |
- 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
- 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Written informed consent
- Diagnosis of locally advanced or metastatic malignancy
- Prior administration of standard treatment for primary and relapsed malignancy
- Eastern Cooperative Oncology Group Performance Status ≤1
- 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
Main Exclusion Criteria:
- Hematological malignancies and primary brain tumors.
- Concurrent treatment in another interventional clinical trial
- Prior treatment with PARP inhibitors
- Persistent toxicity (≥Grade 2 according to CTCAE 4.03)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127215
Contact: Richard Schlenk, MD | +49622156 ext 6228 | studienzentrale@nct-heidelberg.de |
Germany | |
National Center for Tumordiseases (NCT) | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: R. Schlenk, MD +49622156 ext 6228 studienzentrale@nct-heidelberg.de |
Principal Investigator: | Stefan Froehling, MD | NCT / DKFZ Heidelberg |
Responsible Party: | National Center for Tumor Diseases, Heidelberg |
ClinicalTrials.gov Identifier: | NCT03127215 |
Other Study ID Numbers: |
NCT-2017-0417 |
First Posted: | April 25, 2017 Key Record Dates |
Last Update Posted: | November 7, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
DNA Repair-Deficiency Disorders Metabolic Diseases Olaparib Trabectedin Poly(ADP-ribose) Polymerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents |