A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01920061 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-382


This study will evaluate PF-05212384 (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.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - 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, 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: - 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.
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