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

Completed · Phase 3

Conditions studied: Ovarian Cancer

In brief

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).

Key facts

Study ID

NCT02421588

Run by

PharmaMar

People needed

442

Starts

2015-05-01

Expected to finish

2018-10-12

Last updated by the study team

2020-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1112 — Peoria, Arizona, United States
• 1102 — Greenbrae, California, United States
• 1103 — La Jolla, California, United States
• 1116 — Los Angeles, California, United States
• 1120 — Los Angeles, California, United States
• 1113 — Palo Alto, California, United States
• 1111 — San Francisco, California, United States
• 1122 — Santa Maria, California, United States
• 1123 — West Hills, California, United States
• 1109 — Augusta, Georgia, United States
• 1104 — Indianapolis, Indiana, United States
• 1110 — Covington, Louisiana, United States
• 1124 — Scarborough, Maine, United States
• 1121 — Brick, New Jersey, United States
• 1127 — Albany, New York, United States
• 1105 — New York, New York, United States
• 1117 — Asheville, North Carolina, United States
• 1101 — Charlotte, North Carolina, United States
• 1125 — Charlotte, North Carolina, United States
• 1108 — Durham, North Carolina, United States
• 1107 — Columbus, Ohio, United States
• 1118 — Dayton, Ohio, United States
• 1119 — Pittsburgh, Pennsylvania, United States
• 1115 — Greenville, South Carolina, United States
• 1129 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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