A Trial In Patients With Advanced Cancer And Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878189
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Neoplasms by Histologic Type Drug: PF-03084014 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial Of Pf-03084014 In Patients With Advanced Solid Tumor Malignancy And T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Actual Study Start Date : June 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 28 days ]
    First cycle dose limiting toxicity (DLT) rate

  2. 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 ]

Secondary Outcome Measures :
  1. Concentrations of PF 03084014 and dexamethasone at selected timepoints [ Time Frame: 2 years ]
  2. Serum pharmacokinetic parameters of PF-03084014 [ Time Frame: 2 years ]
  3. Changes in NICD levels and expression levels of Notch1 target genes [ Time Frame: 28 days ]
  4. Objective tumor response, overall response rate, time to tumor progression, progression free survival, and duration of response [ Time Frame: 2 years ]
  5. QTc interval [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878189

United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
University of Colorado Denver CTRC
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital Clinical Laboratory
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Ferber Cancer institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Center / Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
DIPRTMNT CLIN Scienze RADIOL e Istocitopatologiche
Bologna, Italy, 40138
Istituto di Ematologia Seragnoli
Bologna, Italy, 40138
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00878189     History of Changes
Other Study ID Numbers: A8641014
2010-022036-36 ( EudraCT Number )
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type