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

Last updated on November 10, 2019

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

NCT01937715
Pfizer
Terminated
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

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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 DescriptionNot 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 DateAugust 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 CountriesBelgium,   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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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