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

NCT01739764 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GO283992012-003144-80
• Study Type: interventional
• Target: 215
• Locations: 24 countries
• Sites: 82

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

Outcome Measures

Primary Outcomes (1)

• Dose Intensity of Vemurafenib

  Dose Intensity was defined as (total actual doses taken/total planned doses) \*100, where total planned doses = prescribed doses \* planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.

  Baseline up to a maximum of 7 years.

Secondary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).

Study Arms (3)

Vemurafenib 480mg BID

EXPERIMENTAL

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.

Drug: Vemurafenib

Vemurafenib 720mg BID

EXPERIMENTAL

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.

Drug: Vemurafenib

Vemurafenib 960mg BID

EXPERIMENTAL

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.

Drug: Vemurafenib

Interventions

Vemurafenib DRUG

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

Also known as: Zelboraf

Vemurafenib 480mg BID; Vemurafenib 720mg BID; Vemurafenib 960mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (83)

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

UCLA Department of Medicine

Los Angeles, California, 90024, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Chicago Medical Center; Medicine, Section of Pulmonary

Chicago, Illinois, 60637, United States

Location

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

Sioux City, Iowa, 51108, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

New York University Medical Center PRIME

New York, New York, 10016, United States

Location

Evelyn H. Lauder Center

New York, New York, 10065, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Mary Crowley Medical Research Center; Oncology

Dallas, Texas, 75246, United States

Location

M D Anderson Physician Network

Webster, Texas, 77598, United States

Location

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, 98195, United States

Location

N.N. Alexandrov National Cancer Centre of Belarus

Minsk District, 223040, Belarus

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Clinic Centre Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Location

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

Montreal, Quebec, H3T 1E2, Canada

Location

Clinical Hospital Center Sestre Milosrdnice

Zagreb, 10000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Bank of Cyprus Oncology Center

Nicosia, 2006, Cyprus

Location

Medical Research Institute

Alexandria, 21131, Egypt

Location

National Cancer Institute

Cairo, 11796, Egypt

Location

Mansoura University Hospital

Dakahlia, 324, Egypt

Location

Gharbia Cancer Society

Tanta, Egypt

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

Mainz, 55131, Germany

Location

Universitätsklinikum Wurzburg

Würzburg, 97080, Germany

Location

University General Hospital of Heraklion

Crete, 711 10, Greece

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

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

Budapest, H-1077, Hungary

Location

Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

Debrecen, 4012, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 7624, Hungary

Location

Rambam Health Care Campus

Haifa, 3109600, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

Ramat Gan, 5266202, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

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

Milan, Lombardy, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56100, Italy

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, 1099-023, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

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

Moskva, Moscow Oblast, 115478, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', 420029, Russia

Location

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

Krasnodar, 350040, Russia

Location

Moscow city oncology hospital #62 of Moscow Healthcare Department

Moscow, 143423, Russia

Location

St. Petersburg SHI "City Clinical Oncology Dispensary"

Saint Petersburg, 197022, Russia

Location

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

Ufa, 450054, Russia

Location

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, 11070, Serbia

Location

Cape Town Oncology Trials

Cape Town, 7570, South Africa

Location

Wits Donald Gordon Clinical Trial Centre; Medical Oncology

Parktown, Johannesburg, 2193, South Africa

Location

Cancercare Langenhoven Drive Oncology Centre

Port Elizabeth, 6045, South Africa

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Samsung Medical Center

Seoul, (0)6351, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Regional Universitario de Malaga; Oncologia

Málaga, Malaga, 29010, Spain

Location

Hospital General Universitario Santa Lucia

Cartagena (Murcia), Murcia, 30202, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Paz

Madrid, 280146, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

Madrid, 28050, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Royal Marsden Hospital

Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Vemurafenib

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 3, 2012
• Study Start: February 19, 2013
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: January 7, 2021
• Results First Posted: November 18, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1); IL (4); RO (1); BO (2); NZ (2); BE (1); SE (2); CR (2); ZA (3); PT (2); NL (1); RU (6); IT (2); US (12); KR (5); HU (5); GB (3); DE (3); GR (1); ES (16); BR (1); CA (1); EG (4); FR (2)