A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:September 10, 2013
End Date:October 18, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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).


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.
We found this trial at
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Los Angeles, California 90095
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1720 2nd Ave S
Birmingham, Alabama 35233
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1600 Divisadero Street
San Francisco, California 94115
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UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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Aurora, Colorado 80045
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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171 Ashley Avenue
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Detroit, Michigan 48201
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Detroit, Michigan 48201
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Los Angeles, California 90095
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Los Angeles, California 90095
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1600 Midtown Avenue
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North Charleston, South Carolina 29406
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Philadelphia, Pennsylvania 19111
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Santa Monica, California 90404
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