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Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Colorectal Cancer

Intervention: combination panitumumab and vemurafenib (Drug)

Phase: N/A

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Rona Yaeger, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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 likely to respond to this new drug combination.

Clinical Details

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

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

Primary outcome: objective response rate (ORR)

Secondary outcome:

progression-free survival (PFS)

overall survival (OS)

safety, tolerability, and adverse event profile

efficacy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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: 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. Exclusion Criteria: 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.

- 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.

Locations and Contacts

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: January 2013
Last updated: March 18, 2015

Page last updated: August 23, 2015

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