Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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3 August 2015 |
Main ID: |
NCT02439268 |
Date of registration:
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26/04/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Safety and Efficacy Study of Vemurafenib (CT) Compared With Vemurafenib (Zelbolaf®) in Advanced Patients Harboring the V600 BRAF Mutation
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Scientific title:
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The Safety and Efficacy Study of Vemurafenib (CT) Compared With Vemurafenib (Zelbolaf®) in Advanced Patients Harboring the V600 BRAF Mutation |
Date of first enrolment:
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September 2014 |
Target sample size:
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100 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02439268 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belarus
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Russian Federation
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Ukraine
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Contacts
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Name:
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Viktor Lanevskij, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed written informed consent
- Recheck the results of histological studies and paraffin blocks
- Histologically confirmed cancer that is either Stage IIIc (unresectable) or ---Stage
IV (metastatic), and determined to be BRAF V600E or V600K mutation-positive by the
local laboratory.
- Measurable tumor by physical or radiographic examination
- Subjects must not have had more than 1 previous treatment regimen with chemotherapy,
interferon, or IL-2 for metastatic melanoma
- All prior anti-cancer treatment-related toxicities (except alopecia) must be <= Grade
1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate baseline organ function as defined by: absolute neutrophil count (ANC) >=
1.2 × 109/L; Hemoglobin >= 9 g/dL; Platelet count >= 100 x 109/L; prothrombin time
(PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) <=
1.5 x upper limit of normal (ULN); Albumin >= 2.5 g/dL; Total bilirubin <= 1.5 x ULN;
aspartate aminotransferase (AST) and alanine transaminase (ALT) <= 2.0 x ULN;
Creatinine <=1.5 mg/mL; Left Ventricular Ejection fraction (LVEF) >= lower limit of
normal (LLN) by ECHO Women of childbearing potential must have a negative serum
pregnancy test within 7 days prior to randomization and agree to use effective
contraception, during the study, and for 30 days after the last dose of study
treatment
- Men with a female partner of childbearing potential must have either had a prior
vasectomy or agree to use effective contraception for at least 2 weeks prior to the
first dose of study treatment until 16 weeks after the last dose of study treatment
to allow for clearance of any altered sperm
- Able to swallow and retain orally administered study treatment and does not have any
clinically significant gastrointestinal abnormalities that may alter absorption such
as malabsorption syndrome or major resection of the stomach or bowels
Exclusion Criteria:
- Prior treatment with a BRAF inhibitors or a MEK inhibitor (including but not limited
to trametinib, AZD6244, and RDEA119) or ipilimumab or any other agent targeting a
T-cell immunomodulatory pathway (including, but not limited to CTLA-4, PD-1, 4-1BB,
OX40, GITR, CD27, and CD28)
- Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity,
biologic therapy, or immunotherapy within 21 days prior to randomization and/or daily
or weekly chemotherapy without the potential for delayed toxicity within 14 days
prior to randomization
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C
------Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV
infection)
- A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- All known lesions were previously treated with surgery or stereotactic surgery
(whole-brain radiation is not allowed unless given after definitive treatment with
surgery or stereotactic surgery)
- Brain lesion(s), if still present, must be confirmed stable (i.e., no increase in
lesion size) for >= 6 weeks prior to randomization (stability must be confirmed with
two consecutive magnetic resonance image (MRI) or computed tomography (CT) scans with
contrast,
- Asymptomatic with no corticosteroid requirements for >= 4 weeks prior to
randomization,
- No enzyme inducing anticonvulsants for >= 4 weeks prior to randomization
- A history or evidence of cardiovascular risk including any of the following LVEF <
LLN for the institution
- A corrected QT interval >=480 msec (e.g. Bazett's formula [QTcB])
- A history or evidence of current clinically significant uncontrolled arrhythmias
(exception: subjects with controlled atrial fibrillation for > 30 days prior to
randomization are eligible)
- A history (within 6 months prior to first dose of study treatment) of acute coronary
syndromes (including myocardial infarction or unstable angina), coronary angioplasty
- A history or evidence of current >=Class II congestive heart failure as defined by
the New York Heart Association (NYHA)
- Treatment refractory hypertension defined as systolic blood pressure >140 millimetres
of mercury (mmHg) and/or diastolic blood pressure >90 mmHg which cannot be controlled
by antihypertensive therapy
- Patients with intra-cardiac defibrillators
- Abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (subjects
with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on
study). Subjects with moderate valvular thickening should not be entered on study
- A history or current evidence/risk of retinal vein occlusion (RVO) or Central serous
retinopathy (CSR) including
- Presence of predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular
hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history
of hyperviscosity or hypercoagulability syndromes), or
- Visible retinal pathology as assessed by ophthalmic examination that is considered a
risk factor for RVO or CSR such as evidence of new optic disc cupping; Evidence of
new visual field defects on automated perimetry; Intraocular pressure >21 mmHg as
measured by tonography
- History of any of the following diseases: inflammatory bowel disease or any other
autoimmune bowel disease; systemic lupus erythematosus; rheumatoid arthritis; or any
autoimmune ocular diseases. Patients with active autoimmune disease or a history of
autoimmune disease other than those mentioned above must be approved by the GSK
medical monitor
- Active pneumonitis or interstitial lung disease
- Lactating female
- History of another malignancy (Exception: Subjects who have been disease-free for 3
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible)
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions that could interfere with subject's safety, obtaining informed consent or
compliance to the study procedures
- Any prohibited medication
- Administration of an investigational study treatment within 28 days or 5 half-lives,
whichever is longer, preceding the first do
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Recurrent/Refractory BRAFV600E-mutant Gliomas
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Advanced BRAF-mutant Cancers
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Melanoma
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Advanced Cancers
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Colorectal Cancer
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Intervention(s)
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Drug: Vemurafenib
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Drug: Vemurafenib (CT)
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Primary Outcome(s)
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Objective response rate (ORR)
[Time Frame: Time Frame: 12 months]
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Toxicities will be assessed through the NCI-Common Terminology Criteria for Adverse Events version 4.0, individually reported and summarized.
[Time Frame: Time Frame: 12 months]
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Secondary Outcome(s)
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Number of Participants With Progression Free Survival (PFS)
[Time Frame: Time Frame: 12 months]
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Secondary ID(s)
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XTPTC-303-88
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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