NCT02399943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

March 23, 2015

Last Update Submit

May 12, 2022

Conditions

Colorectal CancerKRAS WildtypeNRAS WildtypeBRAF Wildtype

Outcome Measures

Primary Outcomes (1)

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

    by RECIST 1.1 criteria

    24 weeks

Secondary Outcomes (4)

  • Frequency and proportion of patients who experience side effects.

    3 years

  • Proportion of subjects achieving either a complete or partial tumor response

    3 years

  • Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed

    3 years

  • Date of first confirmed response to the first date in which progression is observed

    3 years

Study Arms (1)

Trametinib and Panitumumab

EXPERIMENTAL

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

Drug: TrametinibDrug: Panitumumab

Interventions

TrametinibDRUG
Also known as: MEKINIST
Trametinib and Panitumumab
PanitumumabDRUG
Also known as: VECTIBIX
Trametinib and Panitumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34417144DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trametinibPanitumumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Philippe Bedard, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2019

Study Completion

March 31, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations

CA(1)