Status:
TERMINATED
Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer
Lead Sponsor:
Pfizer
Conditions:
Ovarian Cancer
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Pegylated liposomal doxorubicin (PLD), a type of chemotherapy, is a standard treatment option for patients with platinum-resistant ovarian cancer. However, despite being consider a standard treatment ...
Detailed Description
Pegylated liposomal doxorubicin (PLD) is a standard treatment option for patients with platinum-resistant ovarian cancer who are not candidates for chemotherapy in combination with bevacizumab. Howeve...
Eligibility Criteria
Inclusion
- Key
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Histologically-confirmed epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC).
- Platinum-resistant recurrent (disease progression ≤6 months after the most recent platinum-based treatment regimen (date calculated from the last administered dose of platinum) or the participant is no longer able to receive.
- or declined treatment with platinum-based chemotherapy.
- Progression with standard of care therapies, including platinum-based therapies, poly ADP ribose polymerase (PARP) inhibitors or bevacizumab in the platinum-sensitive setting or intolerability to such therapies or patient refusal
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Adequate organ and hematologic function
- No more than four prior treatment regimens for platinum-resistant disease
- All adverse events from prior treatment must be the Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
- Key
Exclusion
- Platinum-refractory disease (defined as progression on or within 3 months of completing primary first-line platinum-based treatment)
- Non-epithelial histology, including malignant mixed Mullerian tumors
- Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade serous ovarian cancer or carcinosarcoma
- History of acute coronary syndromes.
- History of or current Class II, III, or IV heart failure.
- History or evidence of known central nervous system (CNS) metastases or carcinomatous meningitis.
- Significant bleeding disorders, vasculitis or a significant bleeding episode from the Gastrointestinal (GI) tract.
- History of severe hypersensitivity reactions to antibodies.
- Systemic steroid therapy.
- History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.
- Prior organ transplantation including allogenic or autologous stem cell transplantation
- Prior treatment with anti-cluster of differentiation 47 (CD47) or anti-SIRPα therapy.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05261490
Start Date
August 1 2022
End Date
February 15 2024
Last Update
November 19 2024
Active Locations (18)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
2
Baptist Hospital of Miami
Miami, Florida, United States, 33176
3
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
4
Orlando Health Cancer Institute Gynecologic Cancer Center
Orlando, Florida, United States, 32806