A study to assess the detection of the BRAF V600 mutation on cfDNA from plasma in patients with advanced melanoma

Phase 1

Active, not recruiting

• Conditions: Melanoma; MedDRA version: 20.0 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001731-20-PL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-11
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 208

Inclusion Criteria

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

Exclusion Criteria

Cancer-Related Exclusion Criteria:
1. History of prior RAF or mitogen-activated protein kinase (MEK)
pathway inhibitor treatment
2.
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