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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01898585
Other study ID # ML28711
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 17, 2013
Est. completion date May 22, 2019

Study information

Verified date January 2020
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 22, 2019
Est. primary completion date May 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults patients >= 18 years of age

- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobasĀ® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist

- Patients with either measurable or non-measurable disease (RECIST Version 1.1)

- Patients may or may not have received prior systemic therapy for metastatic melanoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

- Adequate hematological, renal, and liver function

- Negative serum pregnancy test at screening

- Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study

Exclusion Criteria:

- Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib

- Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.

- Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study

- Known hypersensitivity to vemurafenib or another BRAF inhibitor

- Pregnant or lactating women

- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.

- Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zelboraf
Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.

Locations

Country Name City State
South Africa National Hospital; Oncotherapy Dept Bloemfontein
South Africa Cancercare Cape Town
South Africa Cape Town Oncology Trials Cape Town
South Africa Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept Cape Town
South Africa Cancercare George
South Africa Mary Potter Oncology Centre Groenkloof
South Africa Medical Oncology Centre of Rosebank; Oncology Johannesburg
South Africa University of Pretoria; Department of Medical Oncology Pretoria
South Africa Sandton Oncology Medical Group Sandton

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Incidence of adverse events 12 months
Secondary Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) 12 months
Secondary Progression free survival 12 months
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