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A Study Of PF-05212384 Plus F...

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

NCT ID: NCT01937715

Last Updated: 2016-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

PF-05212384 plus FOLFIRI

Group Type EXPERIMENTAL

PF-05212384

Intervention Type DRUG

PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly

FOLFIRI regimen

Intervention Type DRUG

The RP2D/MTD dose of FOLFIRI regimen every 2 weeks

Arm B

Bevacizumab plus FOLFIRI

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type BIOLOGICAL

5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks

FOLFIRI

Intervention Type DRUG

Full dose FOLFIRI regimen every 2 weeks

Interventions

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PF-05212384

PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly

Intervention Type DRUG

FOLFIRI regimen

The RP2D/MTD dose of FOLFIRI regimen every 2 weeks

Intervention Type DRUG

Bevacizumab

5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks

Intervention Type BIOLOGICAL

FOLFIRI

Full dose FOLFIRI regimen every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, United States

Site Status