Status:
COMPLETED
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
Lead Sponsor:
Pfizer
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safet...
Eligibility Criteria
Inclusion
- Cisplatin Combination Expansion:
- Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.
- Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.
- Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.
- Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.
- Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
- Eastern Cooperative Oncology Group \[ECOG\] performance must be 0 or 1.
- Adequate bone marrow, renal and liver function.
Exclusion
- Prior therapy for Cisplatin Combination Expansion:
- Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;
- Prior radiation to \>25% bone marrow as estimated by the Investigator.
- Patients with known symptomatic brain metastases.
- Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.
- Major surgery within 4 weeks of the baseline disease assessments.
- \>2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.
- Active bacterial, fungal or viral infection.
- Uncontrolled or significant cardiovascular disease.
Key Trial Info
Start Date :
September 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01920061
Start Date
September 10 2013
End Date
January 8 2020
Last Update
September 13 2022
Active Locations (29)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
4
UCLA Hematology Oncology
Los Angeles, California, United States, 90095