Clinical trial · Interventional
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)
NCT02421588CI-TRIAL-00044431CORAILcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lurbinectedin (PM01183) | Drug | Lurbinectedin | ALIAS |
| Pegylated liposomal doxorubicin (PLD) | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- lurbinectedin (PM01183)
- interventionNames
- Drug: Lurbinectedin (PM01183)
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- pegylated liposomal doxorubicin OR topotecan
- interventionNames
- Drug: Pegylated liposomal doxorubicin (PLD)
- Drug: Topotecan
Primary outcomes (1)
- measure
- Progression-free Survival by Independent Review Committee
- timeFrame
- Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer. * Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy). * Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria * No more than three prior systemic chemotherapy regimens * Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2 * Adequate hematological, renal, metabolic and hepatic function Exclusion Criteria: * Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness * Prior treatment with PM01183, trabectedin, or with both PLD and topotecan. * Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
References
Publications (2)
- DERIVEDNewhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. PMID 37407274
- DERIVEDGaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11. PMID 34521554