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

Last updated on December 15, 2017

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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Colorectal Carcinoma
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
August 2015
August 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Spain,   United States
Belgium,   Germany,   Italy,   Korea, Republic of
 
NCT01937715
B2151007
2013-002096-18 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

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

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