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A Trial In Patients With Advanced Cancer And Leukemia

Last updated on November 13, 2019

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Study Location
Anschutz Cancer Pavilion
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms by Histologic Type
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00878189
Pfizer
Completed
A Trial In Patients With Advanced Cancer And Leukemia

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Descriptive Information
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 SummaryThis is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients with advanced cancer and leukemia
Detailed DescriptionNot 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 *


*   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
 (submitted: April 3, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
60
Actual Study Completion Date  ICMJE November 22, 2016
Actual Primary Completion DateJanuary 10, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Pfizer Clinical Trials Contact Center

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