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A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer

18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer

Inclusion Criteria:

- 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

- 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


Absolute neutrophil count (ANC) ≥1,500/μL Platelets ≥100,000/μL Hemoglobin ≥8g/dL


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


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.

Exclusion Criteria:

Any patient meeting any of the following criteria is not eligible to participate in this

- 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.

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective response rate (ORR)

Outcome Description:

Overall response will be estimated based on best response to this combination in six months of treatment.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Rona Yaeger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • Vemurafenib
  • Panitumumab
  • V600E BRAF mutation
  • colon
  • 12-221
  • Colorectal Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021