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A Phase 1 Trial Of PF-03084014 In Patients With Advanced Solid Tumor Malignancy And T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma


Phase 1
16 Years
N/A
Open (Enrolling)
Both
Neoplasms by Histologic Type

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Trial Information

A Phase 1 Trial Of PF-03084014 In Patients With Advanced Solid Tumor Malignancy And T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Dose-limiting toxicities (DLT)

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8641014

NCT ID:

NCT00878189

Start Date:

June 2009

Completion Date:

March 2015

Related Keywords:

  • Neoplasms by Histologic Type
  • Phase 1 dose escalation study in advanced solid tumor malignancy and leukemia
  • Neoplasms
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasms by Histologic Type
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site North Adams, Massachusetts  01247