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A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Solid Tumors


Inclusion Criteria:



- Histological or cytological diagnosis of advanced/metastatic solid tumor

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

Exclusion Criteria:

- Patients with known symptomatic brain metastases requiring steroids

- Current active treatment on another clinical trial

- Major surgery or radiation therapy within 4-weeks of starting study treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

First cycle dose limiting toxicities (DLTs)

Outcome Time Frame:

10 months

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:

B1371002

NCT ID:

NCT01286467

Start Date:

May 2011

Completion Date:

December 2012

Related Keywords:

  • Solid Tumors
  • PF-04449913
  • Hedgehog Inhibitor
  • Solid tumor
  • Pharmacokinetics
  • Safety
  • Pharmacodynamics
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteNorth Adams, Massachusetts  01247