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.
- 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
- Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.
- Adequate bone marrow, renal and liver function.
- Patients with known symptomatic brain metastases.
- Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the
- 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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Gene sequence data
Objective tumor response
Levels of PI3K pathway protein biomarkers