A Study Of PF-04449913 In Select Hematologic Malignancies

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00953758
• Collaborator: (none)
• Enrollment: 47
• Locations: 6
• Arm: 1
• Duration (Months): 35.1
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: PF-04449913	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 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 Hematologic Malignancies
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. First cycle dose limiting toxicities (Phase 1a) [12 months]

Secondary Outcome Measures

1. Modulation of Pharmacodynamic biomarkers [12 months]

2. Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913 [12 months]

3. Overall response (OR), time to progression (TTP), duration of response and progression-free survival (PFS) as defined by disease specific clinical practice guidelines [12 months]

4. QTc interval [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response.

• ECOG performance status 0 to 2

• Adequate organ function

Exclusion Criteria:

• Patients with active CNS disease

• Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer

• Active GVHD other than Grade 1 skin involvement

• Known malabsorption syndrome

• Patient has an active, life threatening or clinically significant uncontrolled systemic infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	La Jolla	California	United States	92037
2	Pfizer Investigational Site	La Jolla	California	United States	92093
3	Pfizer Investigational Site	San Diego	California	United States	92103
4	Pfizer Investigational Site	Houston	Texas	United States	77030-4009
5	Pfizer Investigational Site	Seattle	Washington	United States	98109-1023
6	Pfizer Investigational Site	Bologna		Italy	40138

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00953758
• Other Study ID Numbers: B1371001
• First Posted: Aug 6, 2009
• Last Update Posted: Dec 10, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Pfizer: Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Dec 10, 2013