Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02421588 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
A Phase 3 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT02421588: Completed Phase 3 study, sponsored by PharmaMar.
NCT02421588 is a Phase 3 study that has completed, run by PharmaMar. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02421588, a Phase 3 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study 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).
Primary Outcome
The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Interventions
- DRUG Topotecan
- DRUG Pegylated liposomal doxorubicin (PLD)
- DRUG Lurbinectedin (PM01183)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-10-12 |
| Phase | Phase 3 |
What the finished NCT02421588 record still lists
NCT02421588 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Topotecan is the first listed.
NCT02421588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02421588 about?
NCT02421588 is a clinical study titled "Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients". 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 to...
What is the current status of trial NCT02421588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2015-05. Estimated completion is 2018-10-12.
What interventions are being tested in trial NCT02421588?
The interventions under investigation include: Topotecan (DRUG), Pegylated liposomal doxorubicin (PLD) (DRUG), Lurbinectedin (PM01183) (DRUG).
Who is sponsoring clinical trial NCT02421588?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02421588's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704766 · 442 participants · NA
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
- NCT04657068 · 442 participants · Phase 1
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
- NCT05410145 · 442 participants · Phase 1
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
- NCT06659029 · 442 participants
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia