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Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

NCT02421588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2020-04-03

Study results available
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Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).

Conditions

Interventions

DRUG

Lurbinectedin (PM01183)

DRUG

Pegylated liposomal doxorubicin (PLD)

DRUG

Topotecan

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-10-12
Completion
2018-10-12

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02421588 on ClinicalTrials.gov