An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

NCT ID: NCT01739764

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-19
• Study Completion Date: 2020-02-17

Brief Summary

This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vemurafenib 480mg BID

Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).

Vemurafenib 720mg BID

Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).

Vemurafenib 960mg BID

Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).

Interventions

Vemurafenib

Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).

Intervention Type: DRUG

Other Intervention Names

Zelboraf

Eligibility Criteria

Inclusion Criteria

• BRAF V600 mutation-positive malignancy
• Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
• Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
• Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment

Exclusion Criteria

• Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
• Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:

• Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
• Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
• History of malabsorption or other clinically significant metabolic dysfunction
• History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Highlands Oncology Group

Rogers, Arkansas, United States

UCLA Department of Medicine

Los Angeles, California, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

University of Chicago Medical Center; Medicine, Section of Pulmonary

Chicago, Illinois, United States

Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center

Sioux City, Iowa, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

New York University Medical Center PRIME

New York, New York, United States

Evelyn H. Lauder Center

New York, New York, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Mary Crowley Medical Research Center; Oncology

Dallas, Texas, United States

M D Anderson Physician Network

Webster, Texas, United States

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

N.N. Alexandrov National Cancer Centre of Belarus

Minsk District, , Belarus

Institut Jules Bordet

Brussels, , Belgium

University Clinical Center of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

University Clinic Centre Sarajevo

Sarajevo, , Bosnia and Herzegovina

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, Canada

Clinical Hospital Center Sestre Milosrdnice

Zagreb, , Croatia

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Bank of Cyprus Oncology Center

Nicosia, , Cyprus

Medical Research Institute

Alexandria, , Egypt

National Cancer Institute

Cairo, , Egypt

Mansoura University Hospital

Dakahlia, , Egypt

Gharbia Cancer Society

Tanta, , Egypt

Centre Léon Bérard

Lyon, , France

Institut Gustave Roussy

Villejuif, , France

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

Mainz, , Germany

Universitätsklinikum Wurzburg

Würzburg, , Germany

University General Hospital of Heraklion

Crete, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Orszagos Onkologiai Intezet

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

Debrecen, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Rambam Health Care Campus

Haifa, , Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

Ramat Gan, , Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Maastricht University Medical Center

Maastricht, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, , Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Medisprof SRL

Cluj-Napoca, , Romania

FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

Moskva, Moscow Oblast, Russia

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', , Russia

SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2

Krasnodar, , Russia

Moscow city oncology hospital #62 of Moscow Healthcare Department

Moscow, , Russia

St. Petersburg SHI "City Clinical Oncology Dispensary"

Saint Petersburg, , Russia

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

Ufa, , Russia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, , Serbia

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Cape Town Oncology Trials

Cape Town, , South Africa

Wits Donald Gordon Clinical Trial Centre; Medical Oncology

Parktown, Johannesburg, , South Africa

Cancercare Langenhoven Drive Oncology Centre

Port Elizabeth, , South Africa

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, Spain

Hospital Regional Universitario de Malaga; Oncologia

Málaga, Malaga, Spain

Hospital General Universitario Santa Lucia

Cartagena (Murcia), Murcia, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

Madrid, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Churchill Hospital

Oxford, , United Kingdom

Royal Marsden Hospital

Surrey, , United Kingdom

Countries

United States; Belarus; Belgium; Bosnia and Herzegovina; Brazil; Canada; Croatia; Cyprus; Egypt; France; Germany; Greece; Hungary; Israel; Italy; Netherlands; New Zealand; Portugal; Romania; Russia; Serbia; South Africa; South Korea; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012-003144-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO28399

Identifier Type: -

Identifier Source: org_study_id