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

NCT01925274

Last updated date
Study Location
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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.
    Other Name: PKI-587
  • Drug: irinotecan
    90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle
    Other Name: Camptosar, Campto, CPT-11
  • 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
    Other Name: Erbitux
  • Drug: Irinotecan
    90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
    Other Name: Camptosar, Campto, CPT-11
Study Arms  ICMJE
  • Experimental: Arm A
    PF-05212384 plus Irinotecan
    Interventions:
    • Drug: PF-05212384
    • Drug: irinotecan
  • Active Comparator: Arm B
    Cetuximab plus Irinotecan
    Interventions:
    • Drug: Cetuximab
    • Drug: Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 15, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
150
Actual Study Completion Date  ICMJE April 6, 2016
Actual Primary Completion Date April 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Spain,   United States
Removed Location Countries Belgium,   Italy
 
Administrative Information
NCT Number  ICMJE NCT01925274
Other Study ID Numbers  ICMJE B2151005
2013-002095-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP