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.
- 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.