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A Study Of PF-04449913 In Select Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

PF-04449913

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

First cycle dose limiting toxicities (Phase 1a)

Secondary Outcome Measures

Modulation of Pharmacodynamic biomarkers

Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913

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

QTc interval

Full Information

NCT ID

NCT00953758

First Posted

August 4, 2009

Last Updated

December 8, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00953758

Brief Title

A Study Of PF-04449913 In Select Hematologic Malignancies

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancies

Keywords

Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PF-04449913

Intervention Description

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

Primary Outcome Measure Information:

Title

First cycle dose limiting toxicities (Phase 1a)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Modulation of Pharmacodynamic biomarkers

Time Frame

12 months

Title

Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913

Time Frame

12 months

Title

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

Time Frame

12 months

Title

QTc interval

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Pfizer Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-1023

Country

United States

Facility Name

Pfizer Investigational Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

33993815

Citation

Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18.

Results Reference

derived

PubMed Identifier

26688487

Citation

Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015 Aug;2(8):e339-46. doi: 10.1016/S2352-3026(15)00096-4. Epub 2015 Jul 26.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371001&StudyName=A%20Study%20Of%20PF-04449913%20In%20Select%20Hematologic%20Malignancies

Description

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A Study Of PF-04449913 In Select Hematologic Malignancies

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