A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
NCT01876251
ABOUT THIS STUDY
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- Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.
- Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
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Descriptive Information | |||||
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Brief Title ICMJE | A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer | ||||
Official Title ICMJE | Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer | ||||
Brief Summary | This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Breast Cancer Metastatic | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: PF-03084014 plus docetaxel
PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m^2 Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE | 30 | ||||
Original Estimated Enrollment ICMJE | 60 | ||||
Actual Study Completion Date ICMJE | December 24, 2015 | ||||
Actual Primary Completion Date | December 24, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, Italy, Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01876251 | ||||
Other Study ID Numbers ICMJE | A8641016 2013-000659-41 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |