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A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02399943
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
82
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).

Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.

Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.

Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trametinib and Panitumumab

Trametinib: 2 mg QD, orally, continuously. Panitumumab: 6 mg/kg, intravenously, Q2W

Drug: Trametinib
Other Names:
  • MEKINIST

    • Drug: Panitumumab
    Other Names:
  • VECTIBIX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients who experience complete response, partial response, or stable disease [24 weeks]

      by RECIST 1.1 criteria

    Secondary Outcome Measures

    1. Frequency and proportion of patients who experience side effects. [3 years]

      by system organ class and preferred term

    2. Proportion of subjects achieving either a complete or partial tumor response [3 years]

      by RECIST 1.1 criteria

    3. Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed [3 years]

    4. Date of first confirmed response to the first date in which progression is observed [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age or older

    • KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy

    • Prior 5-FU, oxaliplatin and irinotecan

    • ECOG Performance Status of 0 or 1

    • Able to swallow/retain oral drugs

    • Able and agree to have provide tumor tissue/have biopsies

    • Agree to use contraception

    • Not pregnant

    • Adequate organ system function

    Exclusion Criteria:

    • Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives

    • Prior EGFR, MEK, or RAF inhibitor or regorafenib

    • Current use of prohibited medications

    • Unresolved side effects

    • GI disease or other condition affecting GI absorption

    • Mucosal or internal bleeding

    • Any major surgery <four weeks

    • HIV, HBV, or HCV positive

    • Active infection

    • Leptomeningeal disease

    • Brain metastases

    • Unacceptable QTcF interval

    • Significant uncontrolled arrhythmias

    • Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.

    • Class II, III, or IV heart failure

    • Other clinically significant ECGs

    • Intra - cardiac defibrillators

    • Cardiac metastases

    • Condition that may interfere with patient safety

    • Hypersensitivity to study drugs

    • Severe or uncontrolled systemic diseases

    • Pregnant or lactating

    • Retinal vein occlusion

    • Interstitial lung disease or pneumonitis

    • Active liver or biliary disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Philippe Bedard, M.D., Princess Margaret Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT02399943
    Other Study ID Numbers:
    • MOBILITY-001
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Panitumumab
    Trametinib

    Study Results

    No Results Posted as of May 16, 2022