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

NCT01925274 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-01-08

Study results available
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Summary

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.

Conditions

Interventions

DRUG

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.

DRUG

irinotecan

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

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

DRUG

Irinotecan

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-15
Primary Completion
2016-04-06
Completion
2016-04-06

Countries

  • United States
  • Japan
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925274 on ClinicalTrials.gov