Breast Cancer Clinical Trial

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)

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 safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT01920061

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 21 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
Westwood Bowyer Clinic
Los Angeles California, 90095, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica California, 90404, United States
UCLA Hematology Oncology
Santa Monica California, 90404, United States
University of Colorado Denver CTO (CTRC)
Aurora Colorado, 80045, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Harper Professional Building
Detroit Michigan, 48201, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina/ University Hospital
Charleston South Carolina, 29425, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
MUSC SCTR Research
Charleston South Carolina, 29425, United States
MUSC Health East Cooper
Mount Pleasant South Carolina, 29464, United States
MUSC Specialty Care-North
North Charleston South Carolina, 29406, United States
British Columbia Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Istituto Europeo di Oncologia - Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
Milano MI, 20141, Italy
Istituto Regina Elena Struttura Complessa Oncologia Medica A
Roma RM, 00144, Italy
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
University College London Hospital, NIHR UCLH Clinical Research Facility
London , W1T 7, United Kingdom
Oxford Cancer Centre
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT01920061

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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