Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors

NCT01927341

Last updated date
Study Location
University of California at Los Angeles Dept of Onc
Los Angeles, California, 90095, 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

- Age ≥ 18 years

- Metastatic colorectal cancer

- Progression on or following standard therapy, or no standard therapy (phase Ib). Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase II)

- Written documentation of mutant or wild-type RAS

- Life expectancy ≥ 3 months

- ECOG performance status ≤ 2

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


Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other
EGFR inhibitors


- Previous treatment with MEK-inhibitors


- History of severe infusion reactions to monoclonal antibodies.


- Symptomatic or untreated leptomeningeal disease


- Symptomatic brain metastasis


- Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed
by ophthalmologic examination at baseline that would be considered a risk factor for
CSR/RVO and history of keratitis.


- Acute or chronic pancreatitis


- Clinically significant cardiac disease


- Not adequate hematologic, renal and hepatic function

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors
Official Title  ICMJE A Phase Ib/II, Open-label, Multi-center, Dose Escalation Study of MEK162 in Combination With Panitumumab in Adult Patients With Mutant RAS or Wild-type RAS Metastatic Colorectal Cancer
Brief Summary The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: MEK162
    Tablet for oral use, 15 mg, BID
  • Drug: Panitumumab
    Intravenous infusion, 20mg/ml concentrate solution for infusion, Q2W (Days 1 and 15 of every cycle)
Study Arms  ICMJE
  • Experimental: Phase Ib: Dose escalation
    Phase Ib: Dose escalation.
    Interventions:
    • Drug: MEK162
    • Drug: Panitumumab
  • Experimental: Phase II: Patients with mutant RAS mCRC
    Patients with mutant RAS mCRC who have not been pretreated with an EGFR inhibitor (EGFRi), including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.
    Interventions:
    • Drug: MEK162
    • Drug: Panitumumab
  • Experimental: Phase II: Patients with acquired mutant RAS mCRC
    Patients with acquired mutant RAS mCRC who have been pretreated with anti-EGFR monoclonal antibody therapy, but have not been pre-treated with EGFR tyrosine kinase inhibitor therapy.
    Interventions:
    • Drug: MEK162
    • Drug: Panitumumab
  • Experimental: Phase II: Patients with WT RAS mCRC (pretreated)
    Patients with WT RAS mCRC who have not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.
    Interventions:
    • Drug: MEK162
    • Drug: Panitumumab
  • Experimental: Phase II: Patients with WT RAS mCRC (not pretreated)
    Patients with WT RAS mCRC who have not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.
    Interventions:
    • Drug: MEK162
    • Drug: Panitumumab
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2020)
53
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2013)
90
Actual Study Completion Date  ICMJE January 25, 2016
Actual Primary Completion Date January 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ? 18 years
  • Metastatic colorectal cancer
  • Progression on or following standard therapy, or no standard therapy (phase Ib). Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase II)
  • Written documentation of mutant or wild-type RAS
  • Life expectancy ? 3 months
  • ECOG performance status ? 2

Exclusion Criteria:

Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other EGFR inhibitors

  • Previous treatment with MEK-inhibitors
  • History of severe infusion reactions to monoclonal antibodies.
  • Symptomatic or untreated leptomeningeal disease
  • Symptomatic brain metastasis
  • Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO and history of keratitis.
  • Acute or chronic pancreatitis
  • Clinically significant cardiac disease
  • Not adequate hematologic, renal and hepatic function
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 Belgium,   Canada,   France,   Italy,   Netherlands,   Spain,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01927341
Other Study ID Numbers  ICMJE CMEK162X2116
2013-001986-18 ( EudraCT Number )
C4211008 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
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 November 2020

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