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)
NCT ID: NCT01920061
Last Updated: 2022-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
110 participants
INTERVENTIONAL
2013-09-10
2020-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Arm A
PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Docetaxel
Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Arm B
PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Cisplatin
Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Arm C
PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Dacomitinib
Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
Expansion Arm 1
PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Cisplatin
Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Expansion Arm 2
PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Cisplatin
Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Interventions
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PF-05212384 (gedatolisib)
PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
Docetaxel
Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Cisplatin
Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2
Dacomitinib
Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology Oncology
Los Angeles, California, United States
Westwood Bowyer Clinic
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States
UCLA Hematology Oncology
Santa Monica, California, United States
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Harper Professional Building
Detroit, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina/ University Hospital
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MUSC SCTR Research
Charleston, South Carolina, United States
MUSC Health East Cooper
Mt. Pleasant, South Carolina, United States
MUSC Specialty Care-North
North Charleston, South Carolina, United States
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Istituto Europeo di Oncologia - Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
Milan, MI, Italy
Istituto Regina Elena Struttura Complessa Oncologia Medica A
Roma, RM, Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
University College London Hospital, NIHR UCLH Clinical Research Facility
London, , United Kingdom
Oxford Cancer Centre
Oxford, , United Kingdom
Countries
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References
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Curigliano G, Shapiro GI, Kristeleit RS, Abdul Razak AR, Leong S, Alsina M, Giordano A, Gelmon KA, Stringer-Reasor E, Vaishampayan UN, Middleton M, Olszanski AJ, Rugo HS, Kern KA, Pathan N, Perea R, Pierce KJ, Mutka SC, Wainberg ZA. A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer. Br J Cancer. 2023 Jan;128(1):30-41. doi: 10.1038/s41416-022-02025-9. Epub 2022 Nov 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-001390-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B2151002
Identifier Type: -
Identifier Source: org_study_id
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