Ovarian Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 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:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

442

Study ID:

NCT02421588

Recruitment Status:

Completed

Sponsor:

PharmaMar

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There is 1 Location for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

442

Study ID:

NCT02421588

Recruitment Status:

Completed

Sponsor:


PharmaMar

How clear is this clinincal trial information?

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