A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

NCT01937715

Last updated date
Study Location
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Contact
1-800-718-1021

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

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Carcinoma
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

- Advanced colorectal carcinoma.

- Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.

- Tumor tissue available at time of screening for molecular profiling.

- Adequate performance status.

- Adequate glucose control, bone marrow, kidney, liver, and heart function.

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


- Participation in other studies involving investigational drug(s) (Phases 1-4) before
the current study begins and/or during study participation.


- Prior irinotecan treatment.


- Prior radiation to the pelvis or abdomen in the metastatic or locally advanced
setting.


- History of Gilbert's syndrome.


- Active brain metastases.


- Deep vein thrombosis in the preceding 2 months.


- History of interstitial lung disease.


- RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing
regimen (unless contraindicated or not considered standard practice per clinical site
or country guidelines).

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Metastatic Colorectal CarcinomaA Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer NCT01937715
  1. Fullerton, California
  2. Irvine, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Northridge, California
  14. Pasadena, California
  15. Santa Maria, California
  16. Santa Monica, California
  17. Santa Monica, California
  18. Valencia, California
  19. Westlake Village, California
  20. Henderson, Nevada
  21. Henderson, Nevada
  22. Henderson, Nevada
  23. Las Vegas, Nevada
  24. Las Vegas, Nevada
  25. Las Vegas, Nevada
  26. Cleveland, Ohio
  27. Spartanburg, South Carolina
  28. Spartanburg, South Carolina
  29. Kennewick, Washington
  30. Richland, Washington
  31. Richland, Washington
  32. Seattle, Washington
  33. Seattle, Washington
  34. Spokane Valley, Washington
  35. Spokane, Washington
  36. Ottawa, Ontario
  37. Toronto, Ontario
  38. Barcelona,
  39. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Official Title  ICMJE An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Brief Summary

This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.

The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Carcinoma
Intervention  ICMJE
  • Drug: PF-05212384
    PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
  • Drug: FOLFIRI regimen
    The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
  • Biological: Bevacizumab
    5 mg/m^2 every 2 weeks or 7.5 mg/m^2 every 3 weeks
  • Drug: FOLFIRI
    Full dose FOLFIRI regimen every 2 weeks
Study Arms  ICMJE
  • Experimental: Arm A
    PF-05212384 plus FOLFIRI
    Interventions:
    • Drug: PF-05212384
    • Drug: FOLFIRI regimen
  • Active Comparator: Arm B
    Bevacizumab plus FOLFIRI
    Interventions:
    • Biological: Bevacizumab
    • Drug: FOLFIRI
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
180
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced colorectal carcinoma.
  • Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
  • Tumor tissue available at time of screening for molecular profiling.
  • Adequate performance status.
  • Adequate glucose control, bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

  • Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
  • Prior irinotecan treatment.
  • Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
  • History of Gilbert's syndrome.
  • Active brain metastases.
  • Deep vein thrombosis in the preceding 2 months.
  • History of interstitial lung disease.
  • RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
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 Canada,   Spain,   United States
Removed Location Countries Belgium,   Germany,   Italy,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT01937715
Other Study ID Numbers  ICMJE B2151007
2013-002096-18 ( EudraCT Number )
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 July 2016

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