Study Stopped
Enrollment to the study was terminated on 11Nvo2014 due to slow recruitment. There were no safety or efficacy issues that contributed to this decision.
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER
2 other identifiers
interventional
19
4 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2013
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedStudy Start
First participant enrolled
November 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2016
CompletedResults Posted
Study results publicly available
April 27, 2017
CompletedJanuary 8, 2019
December 1, 2018
2.4 years
August 15, 2013
January 9, 2017
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) as Assessed by Investigators
Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Secondary Outcomes (30)
Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)
28 days
Percentage of Participants With Objective Response
2 years
Duration of Response
2 years
Overall Survival (OS)
2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
- +25 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALPF-05212384 plus Irinotecan
Arm B
ACTIVE COMPARATORCetuximab plus Irinotecan
Interventions
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.
90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle
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
Eligibility Criteria
You may qualify if:
- 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 \[RECIST\]
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D
Los Angeles, California, 90095-7349, United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California, 90095-7349, United States
UCLA West Medical Pharmacy
Los Angeles, California, 90095-7349, United States
Regulatory Management Only: TRIO-US Central Administration
Los Angeles, California, 90095, United States
TRIO-US Central Administration (Regulatory Management only)
Los Angeles, California, 90095, United States
TRIO_US
Los Angeles, California, 90095, United States
West Valley Hematology/Oncology Med Group
Northridge, California, 91328, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Regulatory Office: Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89014, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Kadlec Medical Center
Richland, Washington, 99352, United States
Outpatient Imaging Center
Richland, Washington, 99352, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
Spokane Valley Cancer Center
Spokane Valley, Washington, 99216, United States
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated by sponsor due to strategic reasons and not due to any safety or efficacy concerns with treatment of PF-05212384.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2013
First Posted
August 19, 2013
Study Start
November 15, 2013
Primary Completion
April 6, 2016
Study Completion
April 6, 2016
Last Updated
January 8, 2019
Results First Posted
April 27, 2017
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.