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Purpose

This study will evaluate PF-05212384 (gedatolisib) 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. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Docetaxel
    Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental
Arm B
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Cisplatin
    Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental
Arm C
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Dacomitinib
    Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
Experimental
Expansion Arm 1
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Cisplatin
    Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental
Expansion Arm 2
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Cisplatin
    Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.