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

Not Recruiting

Trial ID: NCT02421588


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).

Official Title

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Mary Lake Polan Professor

Amer Karam
Amer Karam

Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology

Hans-Christoph Becker, MD, FSABI, FSCCT

Clinical Professor, Radiology


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

   - 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

   - 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


drug: Lurbinectedin (PM01183)

drug: Pegylated liposomal doxorubicin (PLD)

drug: Topotecan

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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