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

NCT01286467

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Solid TumorsRollover Protocol for Prior SU011248 Protocols NCT00798889
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Los Angeles, California
  5. Los Angeles, California
  6. San Francisco, California
  7. San Francisco, California
  8. Santa Monica,, California
  9. Aurora, Colorado
  10. Indianapolis, Indiana
  11. Boston, Massachusetts
  12. Boston, Massachusetts
  13. Boston, Massachusetts
  14. Ann Arbor, Michigan
  15. Detroit, Michigan
  16. Farmington Hills, Michigan
  17. Minneapolis, Minnesota
  18. St. Louis, Missouri
  19. Albuquerque, New Mexico
  20. Albuqurque, New Mexico
  21. New York, New York
  22. New York, New York
  23. New York, New York
  24. Durham, North Carolina
  25. Cleveland, Ohio
  26. Philadelphia, Pennsylvania
  27. Myrtle Beach, South Carolina
  28. Franklin, Tennessee
  29. Gallatin, Tennessee
  30. Hermitage, Tennessee
  31. Lebanon, Tennessee
  32. Murfreesboro, Tennessee
  33. Nashville, Tennessee
  34. Nashville, Tennessee
  35. Nashville, Tennessee
  36. Nashville, Tennessee
  37. Nashville, Tennessee
  38. Nashville, Tennessee
  39. Smyrna, Tennessee
  40. Dallas, Texas
  41. Houston, Texas
  42. Madison, Wisconsin
  43. Randwick, New South Wales
  44. East Melbourne, Victoria
  45. Heidelberg, Victoria
  46. Montreal, Quebec
  47. Villejuif Cedex,
  48. Thessaloniki,
  49. Milano,
  50. Milano,
  51. Nijmegen, Gld
  52. Singapore,
  53. Lund,
  54. Stockholm,
  55. St. Gallen,
  56. Leeds,
  57. London,
  58. London,
  59. Newcastle-Upon-Tyne,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Solid TumorsA Study Of PF-04449913 Administered Alone In Select Solid Tumors NCT01286467
  1. Los Angeles, California
  2. Aurora, Colorado
  3. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Solid TumorsPhase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors NCT00424632
  1. Nashville, Tennessee
  2. Leuven,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Solid TumorsA Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors NCT00615446
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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