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

Trial ID or NCT#

NCT02421588

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.
Gynecologic oncologist, Medical oncologist, Gynecologic oncologist
Mary Lake Polan Professor
Amer Karam
Amer Karam
Gynecologic oncologist
Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology
Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology
Nelson Teng

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov