Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Hope Rugo

Description

Summary

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).

Official Title

A Phase 1b Open-label Three-arm Multi-center Study To Assess The Safety And Tolerability Of Pf-05212384 (pi3k/Mtor Inhibitor) In Combination With Other Anti-tumor Agents

Keywords

Neoplasm Advanced cancer solid tumors PI3K mTOR PI3K/mTOR metastatic Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms Docetaxel Cisplatin Antineoplastic Agents PF-05212384 (gedatolisib) Dacomitinib

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center in progress, not accepting new patients
    San Francisco California 94115 United States
  • (IRB#13-000987) Ronald Reagan UCLA Medical Center in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Ronald Reagan UCLA Medical Center in progress, not accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology Oncology in progress, not accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Westwood Bowyer Clinic in progress, not accepting new patients
    Los Angeles California 90095 United States

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01920061
Phase
Phase 1
Study Type
Interventional
Last Updated