A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
- 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.