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)

Completed · Phase 1

Conditions studied: Neoplasm

In brief

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).

Key facts

Study ID

NCT01920061

Run by

Pfizer

People needed

110

Starts

2013-09-10

Expected to finish

2020-01-08

Last updated by the study team

2022-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology Oncology — Los Angeles, California, United States
• Westwood Bowyer Clinic — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• UCLA Hematology Oncology — Santa Monica, California, United States
• University of Colorado Denver CTO (CTRC) — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Harper Professional Building — Detroit, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina/ University Hospital — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• MUSC SCTR Research — Charleston, South Carolina, United States
• MUSC Health East Cooper — Mt. Pleasant, South Carolina, United States
• MUSC Specialty Care-North — North Charleston, South Carolina, United States
• British Columbia Cancer Agency - Vancouver Centre — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Istituto Europeo di Oncologia - Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative — Milan, MI, Italy
• Istituto Regina Elena Struttura Complessa Oncologia Medica A — Roma, RM, Italy

Full record on ClinicalTrials.gov

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