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)
- 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.
Trial Phase Phase I
Trial Type Basic science
- Primary ID B2151002
- Secondary IDs NCI-2013-01814, 2013-001390-24
- Clinicaltrials.gov ID NCT01920061