Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
NCT ID: NCT02421588
Last Updated: 2020-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2015-05-31
2018-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
lurbinectedin (PM01183)
Lurbinectedin (PM01183)
Arm B
pegylated liposomal doxorubicin
OR
topotecan
Pegylated liposomal doxorubicin (PLD)
Topotecan
Interventions
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Lurbinectedin (PM01183)
Pegylated liposomal doxorubicin (PLD)
Topotecan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Responsible Party
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Locations
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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
1131
Fort Worth, Texas, United States
1128
Houston, Texas, United States
1106
Charlottesville, Virginia, United States
Countries
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References
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Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PM1183-C-004-14
Identifier Type: -
Identifier Source: org_study_id
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