Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
CORAIL
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
1 other identifier
interventional
442
1 country
28
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started May 2015
Shorter than P25 for phase_3 ovarian-cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2018
CompletedResults Posted
Study results publicly available
March 5, 2020
CompletedApril 3, 2020
February 1, 2020
3.5 years
April 10, 2015
February 19, 2020
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival by Independent Review Committee
The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Secondary Outcomes (7)
Progression-free Survival by Investigator's Assessment
Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Overall Survival (OS)
From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years
Overall Response Rate (ORR) by Independent Review Committee
At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Overall Response Rate by Investigator's Assessment
At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Duration of Response by Independent Review Committee
The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
- +2 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALlurbinectedin (PM01183)
Arm B
ACTIVE COMPARATORpegylated liposomal doxorubicin OR topotecan
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaMarlead
Study Sites (28)
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
Related Publications (2)
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.
PMID: 37407274DERIVEDGaillard 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.
PMID: 34521554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pharma Mar S.A.
- Organization
- Pharma Mar S.A.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 20, 2015
Study Start
May 1, 2015
Primary Completion
October 12, 2018
Study Completion
October 12, 2018
Last Updated
April 3, 2020
Results First Posted
March 5, 2020
Record last verified: 2020-02