ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients with advanced cancer that is resistant to standard therapy or for which no standard therapy is available
- Patients with acute T cell leukemia/lymphoblastic lymphoma that is resistant to standard therapy or for which no standard therapy is available
- Men and women >16 years old
- Prior treatment with a gamma secretase inhibitor for treatment of cancer
- Patients taking Tamoxifen
- Patients with active graft versus host disease
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness
- Patients who are pregnant or breast feeding
- Patients with clinical evidence of central nervous system disease
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Descriptive Information | |||||
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Brief Title ICMJE | A Trial In Patients With Advanced Cancer And Leukemia | ||||
Official Title ICMJE | A PHASE I TRIAL OF PF-03084014 IN PATIENTS WITH ADVANCED SOLID TUMOR MALIGNANCY AND T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA | ||||
Brief Summary | This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients with advanced cancer and leukemia | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Neoplasms by Histologic Type | ||||
Intervention ICMJE | Drug: PF-03084014
10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily Other Name: gamma secretase inhibitor | ||||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: PF-03084014 | ||||
Publications * |
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* 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 | Completed | ||||
Actual Enrollment ICMJE | 72 | ||||
Original Estimated Enrollment ICMJE | 60 | ||||
Actual Study Completion Date ICMJE | November 22, 2016 | ||||
Actual Primary Completion Date | January 10, 2013 (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 | 16 Years and older (Child, 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 | Italy, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878189 | ||||
Other Study ID Numbers ICMJE | A8641014 2010-022036-36 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | October 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |