A Trial In Patients With Advanced Cancer And Leukemia

NCT ID: NCT00878189

Last Updated: 2019-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-25

Study Completion Date

2016-11-22

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms by Histologic Type

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-03084014

Intervention Type DRUG

10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily

Interventions

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PF-03084014

10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily

Intervention Type DRUG

Other Intervention Names

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gamma secretase inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

University of Colorado Denver CTRC

Aurora, Colorado, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Massachusetts General Hospital Clinical Laboratory

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Ferber Cancer institute

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Center / Wayne State University

Detroit, Michigan, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

DIPRTMNT CLIN Scienze RADIOL e Istocitopatologiche

Bologna, , Italy

Site Status

Istituto di Ematologia Seragnoli

Bologna, , Italy

Site Status

Countries

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United States Italy

References

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Papayannidis C, DeAngelo DJ, Stock W, Huang B, Shaik MN, Cesari R, Zheng X, Reynolds JM, English PA, Ozeck M, Aster JC, Kuo F, Huang D, Lira PD, McLachlan KR, Kern KA, Garcia-Manero G, Martinelli G. A Phase 1 study of the novel gamma-secretase inhibitor PF-03084014 in patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Blood Cancer J. 2015 Sep 25;5(9):e350. doi: 10.1038/bcj.2015.80. No abstract available.

Reference Type DERIVED
PMID: 26407235 (View on PubMed)

Tabares-Seisdedos R, Rubenstein JL. Inverse cancer comorbidity: a serendipitous opportunity to gain insight into CNS disorders. Nat Rev Neurosci. 2013 Apr;14(4):293-304. doi: 10.1038/nrn3464.

Reference Type DERIVED
PMID: 23511909 (View on PubMed)

Related Links

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Other Identifiers

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2010-022036-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8641014

Identifier Type: -

Identifier Source: org_study_id

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