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 |
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).
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
22
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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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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
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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