Metastatic Colorectal CancerPhase 1NCT01791309
Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer
A Phase 1 study testing combination panitumumab and vemurafenib in people with Metastatic Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in the BRAF gene that may make them more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- combination panitumumab and vemurafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2015
- Phase
- Phase 1
- 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
- Patient must have metastatic colorectal cancer with a V600E BRAF mutation that has been histologically or cytologically-confirmed at MSKCC and has failed to respond to appropriate standard therapy regimens. There is no limit on the number of prior treatment regimens permitted.
- Patient must not have previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab).
- Patient must have accessible disease appropriate for tumor biopsy.
- Patient is male or female and ≥18 years of age on the day of signing informed consent.
- Patient must have a performance status of 0 or 1 on the ECOG Performance Scale.
- Patient must have adequate organ function as indicated by the following laboratory values:
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- Hematological:
- Absolute neutrophil count (ANC) ≥1,500/μL Platelets ≥100,000/μL Hemoglobin ≥8g/dL
- Renal:
- Serum creatinine or calculated creatinine clearance
- ≤1.5 x upper limit of normal (ULN) OR
- ≥60mL/min for patients with creatinine levels <1.5 x institutional ULN
- Hepatic:
- Serum total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN AST (SGOT) and ALT (SGPT) ≤3 x ULN or ≤5 x ULN in patients with known liver metastasis
- Creatinine clearance should be calculated using the Cockcroft-Gault method
- Female patient of childbearing potential who is not surgically sterilized must have a negative serum or urine pregnancy test β-hCG within 72 hours prior to receiving the first dose of study medication.
- Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent.
- Patient is able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis.
Who cannot join
- Any patient meeting any of the following criteria is not eligible to participate in this study:
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), or who has not recovered from the adverse events due to previous agents administered more than 4 weeks prior to study day 1. If the patient has residual toxicity from prior treatment, other than oxaliplatin-related neurotoxicity or bevacizumab-related albuminuria, toxicity must be ≤ grade 1.
- Patient must be at least 4 weeks post major surgical procedure, and all surgical wounds must be adequately healed (in the judgment of the treating investigator).
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of study day 1.
- Patient has evidence of active CNS disease (radiographically unstable, symptomatic lesions). Newly diagnosed, untreated brain metastases are ineligible. However, prior treatment with stereotactic radiosurgery (SRS), whole brain radiotherapy, or surgical resection is allowed if the patient remains without evidence of disease progression in the brain ≥ 6 weeks and has been off corticosteroids for ≥ 3 weeks.
- Patient has known hypersensitivity to the components of study drug or its analogs.
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- Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
- Patient is breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Patient is known to be Human Immunodeficiency Virus (HIV) positive.
- Patient who has a known history of interstitial pneumonitis or pulmonary fibrosis.
- Patient with mean QTc ≥450msec on screening EKG.
- Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or it is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer
The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in the BRAF gene that may make them more likely to respond to this new drug combination.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- combination panitumumab and vemurafenib
- Keywords
- Vemurafenib, Panitumumab, V600E BRAF mutation, colon, 12-221
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination panitumumab and vemurafenibDrug
Treatment will consist of panitumumab 6mg/kg IV every 14 days and vemurafenib 960mg orally twice daily. In patients who initially respond to treatment and later progress, a voluntary biopsy will be requested at the time of relapse to study mechanisms of acquired resistance. This biopsy should consist of at least one frozen core specimen. Every effort will be made to obtain this biopsy within 30 days of discontinuation of treatment and before the initiation of any new tumor-directed therapies.
| Study group | Role | What they receive |
|---|---|---|
| combination panitumumab and vemurafenib | Experimental | This will be a pilot study of the combination panitumumab and vemurafenib in patients with metastatic colorectal cancer with a BRAF V600E mutation. Patients participating in this study must have BRAF V600E mutated metastatic colorectal cancer and not previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab). Receives: Drug: combination panitumumab and vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Overall response will be estimated based on best response to this combination in six months of treatment.
Measured: 6 months
Secondary outcomes (4)
progression-free survival (PFS)
Progression free survival (PFS) is defined as the period elapsing between the date of initiation of therapy and the date of either disease progression or date of death, whichever is earlier.
Measured: 2 years
overall survival (OS)
OS is defined as the interval between the time of initiation of therapy and the date of death from any cause. Patients who are alive at the time of study completion will be censored at the time the patient was last known to be alive.
Measured: 2 years
safety, tolerability, and adverse event profile
The safety endpoints will include all types of adverse experiences, laboratory safety measurements, ECOG performance scale status, and vital signs. Adverse experiences will be graded and recorded throughout the study according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Measured: 1 year
efficacy
using pre- and post-vemurafenib tumor biopsies obtained from the first 10 patients participating in this trial.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Rona Yaeger, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791309
- Sponsor's protocol ID
- 12-221
- Status last verified
- Jan 2016
- First submitted
- 12 Feb 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01791309
- Acronym / sponsor ID
- 12-221
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Vemurafenib, Panitumumab, V600E BRAF mutation, colon, 12-221
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Feb 2013 (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.
The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in the BRAF gene that may make them more likely to respond to this new drug combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination panitumumab and vemurafenib | Experimental | Drug: combination panitumumab and vemurafenibThis will be a pilot study of the combination panitumumab and vemurafenib in patients with metastatic colorectal cancer with a BRAF V600E mutation. Patients participating in this study must have BRAF V600E mutated metastatic colorectal cancer and not previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient must have metastatic colorectal cancer with a V600E BRAF mutation that has been histologically or cytologically-confirmed at MSKCC and has failed to respond to appropriate standard therapy regimens. There is no limit on the number of prior treatment regimens permitted.
- Patient must not have previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab).
- Patient must have accessible disease appropriate for tumor biopsy.
- Patient is male or female and ≥18 years of age on the day of signing informed consent.
- Patient must have a performance status of 0 or 1 on the ECOG Performance Scale.
Key exclusion criteria (13 listed)
- Any patient meeting any of the following criteria is not eligible to participate in this study:
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), or who has not recovered from the adverse events due to previous agents administered more than 4 weeks prior to study day 1. If the patient has residual toxicity from prior treatment, other than oxaliplatin-related neurotoxicity or bevacizumab-related albuminuria, toxicity must be ≤ grade 1.
- Patient must be at least 4 weeks post major surgical procedure, and all surgical wounds must be adequately healed (in the judgment of the treating investigator).
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of study day 1.
- Patient has evidence of active CNS disease (radiographically unstable, symptomatic lesions). Newly diagnosed, untreated brain metastases are ineligible. However, prior treatment with stereotactic radiosurgery (SRS), whole brain radiotherapy, or surgical resection is allowed if the patient remains without evidence of disease progression in the brain ≥ 6 weeks and has been off corticosteroids for ≥ 3 weeks.
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 |
|---|---|---|
| combination panitumumab and vemurafenibTreatment will consist of panitumumab 6mg/kg IV every 14 days and vemurafenib 960mg orally twice daily. In patients who initially respond to treatment and later progress, a voluntary biopsy will be requested at the time of relapse to study mechanisms of acquired resistance. This biopsy should consist of at least one frozen core specimen. Every effort will be made to obtain this biopsy within 30 days of discontinuation of treatment and before the initiation of any new tumor-directed therapies. | Drug | combination panitumumab and vemurafenib |
Primary outcome
objective response rate (ORR)
Time frame: 6 months
Overall response will be estimated based on best response to this combination in six months of treatment.
4 secondary outcomes
progression-free survival (PFS)
Time frame: 2 years
overall survival (OS)
Time frame: 2 years
safety, tolerability, and adverse event profile
Time frame: 1 year
efficacy
Time frame: 2 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 5 Jan 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Rona Yaeger, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing combination panitumumab and vemurafenib in people with Metastatic Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 18 inclusion and 13 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 5 Jan 2016. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
objective response rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.