Colorectal CancerPhase 2NCT02399943
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer
A Phase 2 study testing Trametinib and Panitumumab in people with Colorectal Cancer and KRAS Wildtype, run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, KRAS Wildtype, NRAS Wildtype
- What is being tested?
- Trametinib and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 31 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Agree to use contraception
- Not pregnant
- Adequate organ system function
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
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.
Read more
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.
- Conditions
- Colorectal Cancer, KRAS Wildtype, NRAS Wildtype, BRAF Wildtype
- Being tested
- Trametinib, Panitumumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
Also called MEKINIST
PanitumumabDrug
Also called VECTIBIX
| Study group | Role | What they receive |
|---|---|---|
| Trametinib and Panitumumab | Experimental | Trametinib: 2 mg QD, orally, continuously.
Panitumumab: 6 mg/kg, intravenously, Q2W Receives: Drug: Trametinib; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience complete response, partial response, or stable disease
by RECIST 1.1 criteria
Measured: 24 weeks
Secondary outcomes (4)
Frequency and proportion of patients who experience side effects.
by system organ class and preferred term
Measured: 3 years
Proportion of subjects achieving either a complete or partial tumor response
by RECIST 1.1 criteria
Measured: 3 years
Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed
Measured: 3 years
Date of first confirmed response to the first date in which progression is observed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2019
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Bedard, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399943
- Sponsor's protocol ID
- MOBILITY-001
- Status last verified
- May 2022
- First submitted
- 23 Mar 2015
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34417144
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
- ClinicalTrials.gov ID
- NCT02399943
- Acronym / sponsor ID
- MOBILITY-001
- Conditions
- Colorectal Cancer, KRAS Wildtype, NRAS Wildtype, BRAF Wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trametinib and Panitumumab | Experimental | Drug: Trametinib, Drug: PanitumumabTrametinib: 2 mg QD, orally, continuously. Panitumumab: 6 mg/kg, intravenously, Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrametinibAlso: MEKINIST | Drug | Trametinib and Panitumumab |
| PanitumumabAlso: VECTIBIX | Drug | Trametinib and Panitumumab |
Primary outcome
Percentage of patients who experience complete response, partial response, or stable disease
Time frame: 24 weeks
by RECIST 1.1 criteria
4 secondary outcomes
Frequency and proportion of patients who experience side effects.
Time frame: 3 years
Proportion of subjects achieving either a complete or partial tumor response
Time frame: 3 years
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
Date of first confirmed response to the first date in which progression is observed
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Derived from this study: PubMed 34417144Alshammari 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.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Bedard, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trametinib and Panitumumab in people with Colorectal Cancer and KRAS Wildtype, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who experience complete response, partial response, or stable disease (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.