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Trial record 48 of 318 for:    colon cancer | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT02399943
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Colorectal Cancer KRAS Wildtype NRAS Wildtype BRAF Wildtype Drug: Trametinib Drug: Panitumumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
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 : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trametinib and Panitumumab

Trametinib: 2 mg QD, orally, continuously.

Panitumumab: 6 mg/kg, intravenously, Q2W

Drug: Trametinib
Other Name: MEKINIST

Drug: Panitumumab
Other Name: VECTIBIX




Primary Outcome Measures :
  1. Percentage of patients who experience complete response, partial response, or stable disease [ Time Frame: 24 weeks ]
    by RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Frequency and proportion of patients who experience side effects. [ Time Frame: 3 years ]
    by system organ class and preferred term

  2. Proportion of subjects achieving either a complete or partial tumor response [ Time Frame: 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 [ Time Frame: 3 years ]
  4. Date of first confirmed response to the first date in which progression is observed [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399943


Contacts
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Contact: Philippe Bedard, M.D. 416-946-4534

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Philippe Bedard, M.D.    416-946-4534    Philippe.Bedard@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Philippe Bedard, M.D. Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02399943     History of Changes
Other Study ID Numbers: MOBILITY-001
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Trametinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action