A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-15

Study Completion Date

2016-04-06

Brief Summary

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This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

PF-05212384 plus Irinotecan

Group Type EXPERIMENTAL

PF-05212384

Intervention Type DRUG

30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.

irinotecan

Intervention Type DRUG

90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Arm B

Cetuximab plus Irinotecan

Group Type ACTIVE_COMPARATOR

Cetuximab

Intervention Type DRUG

120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1

Irinotecan

Intervention Type DRUG

90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Interventions

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PF-05212384

30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.

Intervention Type DRUG

irinotecan

90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Intervention Type DRUG

Cetuximab

120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1

Intervention Type DRUG

Irinotecan

90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Intervention Type DRUG

Other Intervention Names

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PKI-587 Camptosar, Campto, CPT-11 Erbitux Camptosar, Campto, CPT-11

Eligibility Criteria

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Inclusion Criteria

* KRAS and NRAS wild type metastatic colorectal cancer
* Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
* Eastern Cooperative Oncology Group \[ECOG\] Performance Status of 0, 1, or 2
* At least one measurable lesion by Response Evaluation Criterion in Solid Tumors \[RECIST\]

Exclusion Criteria

* More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
* Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
* Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
* Prior radiation to the pelvis or abdomen
* Patients with history of interstitial lung disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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