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

Primary Purpose

Colorectal Cancer, KRAS Wildtype, NRAS Wildtype

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Trametinib
Panitumumab
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trametinib and Panitumumab

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of patients who experience complete response, partial response, or stable disease
by RECIST 1.1 criteria

Secondary Outcome Measures

Frequency and proportion of patients who experience side effects.
by system organ class and preferred term
Proportion of subjects achieving either a complete or partial tumor response
by RECIST 1.1 criteria
Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed
Date of first confirmed response to the first date in which progression is observed

Full Information

First Posted
March 23, 2015
Last Updated
May 12, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02399943
Brief Title
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer
Official Title
Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, KRAS Wildtype, NRAS Wildtype, BRAF Wildtype

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trametinib and Panitumumab
Arm Type
Experimental
Arm Description
Trametinib: 2 mg QD, orally, continuously. Panitumumab: 6 mg/kg, intravenously, Q2W
Intervention Type
Drug
Intervention Name(s)
Trametinib
Other Intervention Name(s)
MEKINIST
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
VECTIBIX
Primary Outcome Measure Information:
Title
Percentage of patients who experience complete response, partial response, or stable disease
Description
by RECIST 1.1 criteria
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Frequency and proportion of patients who experience side effects.
Description
by system organ class and preferred term
Time Frame
3 years
Title
Proportion of subjects achieving either a complete or partial tumor response
Description
by RECIST 1.1 criteria
Time Frame
3 years
Title
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
Title
Date of first confirmed response to the first date in which progression is observed
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Bedard, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34417144
Citation
Alshammari K, Aung KL, Zhang T, Razak ARA, Serra S, Stockley T, Wang L, Nguyen J, Spreafico A, Hansen AR, Zwir D, Siu LL, Bedard PL. Phase II Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Dec;20(4):334-341. doi: 10.1016/j.clcc.2021.07.004. Epub 2021 Jul 24.
Results Reference
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A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

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