Clinical trial NCT01739764: An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Official title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dose Intensity of Vemurafenib
timeFrame: Baseline up to a maximum of 7 years.
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Department of Medicine
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center; Medicine, Section of Pulmonary
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: New York
country: United States
facility: New York University Medical Center PRIME
state: New York
city: New York
country: United States
facility: Evelyn H. Lauder Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center; Oncology
state: Texas
city: Webster
country: United States
facility: M D Anderson Physician Network
state: Texas
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Care Alliance
state: Washington
city: Minsk District
country: Belarus
facility: N.N. Alexandrov National Cancer Centre of Belarus
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinic Centre Sarajevo
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Center
city: Alexandria
country: Egypt
facility: Medical Research Institute
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Dakahlia
country: Egypt
facility: Mansoura University Hospital
city: Tanta
country: Egypt
facility: Gharbia Cancer Society
city: Lyon
country: France
facility: Centre Léon Bérard
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
city: Würzburg
country: Germany
facility: Universitätsklinikum Wurzburg
city: Crete
country: Greece
facility: University General Hospital of Heraklion
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Moskva
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement
state: Moskovskaja Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
city: Krasnodar
country: Russian Federation
facility: SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2
city: Moscow
country: Russian Federation
facility: Moscow city oncology hospital #62 of Moscow Healthcare Department
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg SHI "City Clinical Oncology Dispensary"
city: Ufa
country: Russian Federation
facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia; Medical Oncology
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials
city: Parktown, Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology
city: Port Elizabeth
country: South Africa
facility: Cancercare Langenhoven Drive Oncology Centre
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: LA Coruña
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga; Oncologia
state: Malaga
city: Cartagena (Murcia)
country: Spain
facility: Hospital General Universitario Santa Lucia
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: