A Study Of PF-04449913 Administered Alone In Select Solid Tumors

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01286467

Collaborator

(none)

Enrollment

Locations

Arm

19.1

Duration (Months)

7.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: PF-04449913	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: PF-04449913 Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles

Arm

Intervention/Treatment

Experimental: 1

Drug: PF-04449913

Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles

Outcome Measures

Primary Outcome Measures

First cycle dose limiting toxicities (DLTs) [10 months]

Secondary Outcome Measures

Type, incidence, severity (graded by the national cancer institute [NCI] common criteria for Adverse events [CTCAE], timing, seriousness and relatedness of adverse events to PF-04449913 [26 months]
Hedgehog biomarker modulation [26 months]
Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of PF-04449913 [26 months]
QTc interval [26 months]
Objective tumor response [26 months]
Progression free survival [26 months]
Time to progression [26 months]
Duration of response [26 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Los Angeles	California	United States	90033
2	Pfizer Investigational Site	Aurora	Colorado	United States	80045
3	Pfizer Investigational Site	Boston	Massachusetts	United States	02115