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

Pharma Mar

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Lurbinectedin (PM01183)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02421588

PM1183-C-004-14

Details and patient eligibility

About

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).

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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442 participants in 2 patient groups

Arm A

Experimental group

Description:

lurbinectedin (PM01183)

Treatment:

Drug: Lurbinectedin (PM01183)

Arm B

Active Comparator group

Description:

pegylated liposomal doxorubicin OR topotecan

Treatment:

Drug: Pegylated liposomal doxorubicin (PLD)

Drug: Topotecan