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

Pfizer

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Colorectal Carcinoma

Treatments: Drug: FOLFIRI; Biological: Bevacizumab; Drug: FOLFIRI regimen; Drug: PF-05212384

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937715

2013-002096-18 (EudraCT Number)

B2151007

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Arm A

Experimental group

Description:

PF-05212384 plus FOLFIRI

Treatment:

Drug: FOLFIRI regimen

Drug: PF-05212384

Arm B

Active Comparator group

Description:

Bevacizumab plus FOLFIRI

Treatment:

Biological: Bevacizumab

Drug: FOLFIRI