Phase 3
Completed N=442
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Source: ClinicalTrials.gov NCT02421588 ↗Enrolled (actual)
442
Serious AEs
41.0%
Results posted
Mar 2020
Primary outcomePrimary: Progression-free Survival by Independent Review Committee — 3.5; 3.6 months — p=0.6294
◆ Published Evidence
Established
63citations · ~13 / year
Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL).
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).
Linked Publications (2)
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Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL).
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Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival by Independent Review Committee |
3.5; 3.6 | 0.6294 |
| SECONDARY Progression-free Survival by Investigator's Assessment |
3.7; 3.7 | 0.7673 |
| SECONDARY Overall Survival (OS) |
11.4; 10.9 | 0.8021 |
| SECONDARY Overall Response Rate (ORR) by Independent Review Committee |
3; 3; 29; 25; 90; 97 | 0.6772 |
| SECONDARY Overall Response Rate by Investigator's Assessment |
3; 2; 32; 35; 107; 94 | 0.8976 |
| SECONDARY Duration of Response by Independent Review Committee |
4.0; 3.7 | 0.2631 |
| SECONDARY Duration of Response by Investigator's Assessment |
4.3; 3.7 | 0.8276 |
| SECONDARY Best Response According to Tumor Marker Evaluation (CA-125) |
13; 3; 33; 29; 95; 94 | 0.1231 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02421588) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.