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

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NCT01286467

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90033, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological or cytological diagnosis of advanced/metastatic solid tumor

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-04449913 Administered Alone In Select Solid Tumors
Official Title  ICMJE 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
Brief Summary This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: PF-04449913
Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-04449913
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2013)		23
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2011)		70
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286467
Other Study ID Numbers  ICMJE B1371002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP