Trials / Completed
CompletedNCT02421588
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 442 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Lurbinectedin (PM01183) | |
| DRUG | Pegylated liposomal doxorubicin (PLD) | |
| DRUG | Topotecan |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-10-12
- Completion
- 2018-10-12
- First posted
- 2015-04-20
- Last updated
- 2020-04-03
- Results posted
- 2020-03-05
Locations
28 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02421588. Inclusion in this directory is not an endorsement.