A study to assess the detection of the BRAF V600 mutation on cfDNA from plasma in patients with advanced melanoma
- Conditions
- MelanomaMedDRA version: 20.0 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001731-20-BE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 208
General inclusion criteria:
- Male or female patient aged >= 18 years
- Eastern Coorperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hematologic and end organ function (renal and liver)
- Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
- Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule; those conditions should be discussed with the patient before trial entry
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use 2 effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy
a. Females of childbearing potential are defined as sexually mature women without prior oophorectomy or hysterectomy who have had menses within the last 12 months.
b. Females are not considered to be of childbearing potential if amenorrheic for > 12 months but < 2 years and follicle-stimulating hormone (FSH) level > 40 IU/L.
c. Effective forms of contraception include surgical sterilization, a reliable barrier, method with spermicide, birth control pills, or contraceptive hormone implants. Please note that potential interactions between vemurafenib and hormonal contraceptives may decrease the effectiveness of hormonal contraceptives.
d. d.Male patients who are surgically sterilized are required to use barrier methods of contraception
Disease-specific Inclusion Criteria:
- Patients with histologically confirmed cutaneous melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by AJCC 7th edition
- Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue using a validated tissue test
- Patients with measurable or non-measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
Cancer-Related Exclusion Criteria:
1. History of prior RAF or mitogen-activated protein kinase (MEK) pathway inhibitor treatment
2. Treatment related:
a.Palliative radiotherapy within 14 days prior to the first dose of study treatment
b. Use of prior chemotherapy or immunotherapy (incl. treatment with an anti-PD1, or anti-PDL1 or anti-CTLA-4 monoclonal antibody) within 4 weeks before first study drug administration
Exclusion Criteria Based on Organ Function:
- Ocular: Evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/ central serous chorioretinopathy, retinal vein occlusion, or neovascular macular degeneration
- Patients will be excluded if they have one of the following conditions: a) Uncontrolled glaucoma with intra-ocular pressures >= 21 mmHg b) Uncontrolled hypercholesterolemia >= Grade 2 c) Hypertriglyceridemia >= Grade 2 d) Hyperglycemia >= Grade 2
- Cardiac: History of clinically significant cardiac dysfunction
General exclusion criteria:
- Current severe, uncontrolled systemic disease
- Major surgery or traumatic injury within 14 days prior to first dose of study treatment
- History of malabsorption or other condition that would interfere with absorption of study drugs
- the following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
a) St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer)
b) Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method