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A Trial In Patients With Advanced Cancer And Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00878189
First received: April 6, 2009
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients with advanced cancer and leukemia


Condition Intervention Phase
Neoplasms by Histologic Type
 Drug: PF-03084014
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial Of PF-03084014 In Patients With Advanced Solid Tumor Malignancy And T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Overall safety profile characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Concentrations of PF 03084014 and dexamethasone at selected timepoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Serum pharmacokinetic parameters of PF-03084014 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Changes in NICD levels and expression levels of Notch1 target genes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Objective tumor response, overall response rate, time to tumor progression, progression free survival, and duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • QTc interval [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878189

Locations
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030-4009
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00878189     History of Changes
Other Study ID Numbers: A8641014
Study First Received: April 6, 2009
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1 dose escalation study in advanced solid tumor malignancy and leukemia

Additional relevant MeSH terms:
Neoplasms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
 Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013