NCT01286467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2012

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

January 14, 2011

Results QC Date

August 19, 2022

Last Update Submit

August 9, 2023

Conditions

Solid Tumors

Keywords

PF-04449913Hedgehog InhibitorSolid tumorPharmacokineticsSafetyPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)

    Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913

    Baseline up to end of Cycle 1 (Study Day 28)

Secondary Outcomes (21)

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade

    Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])

  • Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade

    Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])

  • Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15

    Baseline and Cycle 1/Day 15

  • Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1

    Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1

  • Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25

    Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

  • +16 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: PF-04449913

Interventions

PF-04449913DRUG

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

1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of advanced/metastatic solid tumor
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Keck Hospital of University of Southern California

Los Angeles, California, 90033, United States

Location

Los Angeles County-University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California/Norris Comprehensive Cancer Center/Investigational Drug Service

Los Angeles, California, 90033, United States

Location

University of Southern California/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Brigham and Women's Hospital (BWH)

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 33993815DERIVED

  • Wagner AJ, Messersmith WA, Shaik MN, Li S, Zheng X, McLachlan KR, Cesari R, Courtney R, Levin WJ, El-Khoueiry AB. A phase I study of PF-04449913, an oral hedgehog inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2015 Mar 1;21(5):1044-51. doi: 10.1158/1078-0432.CCR-14-1116. Epub 2014 Nov 11.

    PMID: 25388167DERIVED

Related Links

MeSH Terms

Interventions

glasdegib

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 31, 2011

Study Start

May 11, 2011

Primary Completion

May 10, 2012

Study Completion

December 28, 2012

Last Updated

March 6, 2024

Results First Posted

March 6, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(9)