Trial Search Results

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

The purpose of this study is to find if Lurbinectedin, the study drug can help delay worsening of epithelian ovarian, fallopian tube or peritoneal cancer when compared to PLD or topotecan among patients who are resistant to platinum.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

PharmaMar

Intervention(s):

  • Drug: Lurbinectedin (PM01183)
  • Drug: Pegylated liposomal doxorubicin (PLD)
  • Drug: Topotecan

Phase:

Phase 3

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