A Trial In Patients With Advanced Cancer And Leukemia - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00878189

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 Leukemia, Lymphoid Leukemia, T-Cell Solid Tumors	Drug: PF-03084014	Phase I

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

First cycle dose limiting toxicity (DLT) rate [ 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 2013
Estimated 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

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Locations

United States, Colorado
Pfizer Investigational Site	Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Pfizer Investigational Site	Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site	Recruiting
Detroit, Michigan, United States, 48201
United States, Texas
Pfizer Investigational Site	Recruiting
Houston, Texas, United States, 77030-4009
Italy
Pfizer Investigational Site	Recruiting
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

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00878189 History of Changes
Other Study ID Numbers:	A8641014
Study First Received:	April 6, 2009
Last Updated:	February 5, 2012
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
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, T-Cell
Neoplasms by Histologic Type

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012