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OpenTrials
Completed

NCT Number: NCT02399943

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

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.

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Key information

Conditions

Colorectal Cancer BRAF Wildtype Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms KRAS Wildtype NRAS Wildtype Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trametinib

Drug

Other names: MEKINIST

Panitumumab

Drug

Other names: VECTIBIX

Primary outcomes

  1. Percentage of patients who experience complete response, partial response, or stable disease

    Time frame: 24 weeks

    by RECIST 1.1 criteria

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies

Important dates

Study start
2015
Primary completion
2019
Study completion
2022
First posted
Mar 26, 2015
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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