Education and Training
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Lurbinectedin (PM01183)
- drug: Pegylated liposomal doxorubicin (PLD)
- drug: Topotecan
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting