An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
- Registration Number
- NCT01739764
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vemurafenib 480mg BID Vemurafenib 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. Vemurafenib 960mg BID Vemurafenib 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. Vemurafenib 720mg BID Vemurafenib 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.
- Primary Outcome Measures
Name Time Method Dose Intensity of Vemurafenib Baseline up to a maximum of 7 years. 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.
- Secondary Outcome Measures
Name Time Method 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). An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Reported are the Percentage of Participants with AEs and Serious Adverse Events (SAEs).
Trial Locations
- Locations (83)
Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center
🇺🇸Sioux City, Iowa, 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
N.N. Alexandrov National Cancer Centre of Belarus
🇧🇾Minsk District, Belarus
UCLA Department of Medicine
🇺🇸Los Angeles, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
New York University Medical Center PRIME
🇺🇸New York, New York, United States
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hospital das Clinicas - UFRGS
🇧🇷Porto Alegre, RS, Brazil
Clinical Hospital Center Sestre Milosrdnice
ðŸ‡ðŸ‡·Zagreb, Croatia
Clinical Hospital Centre Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Bank of Cyprus Oncology Center
🇨🇾Nicosia, Cyprus
Centre Léon Bérard
🇫🇷Lyon, France
Institute for Oncology and Radiology of Serbia; Medical Oncology
🇷🇸Belgrade, Serbia
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
🇪🇸Santander, Cantabria, Spain
University of Chicago Medical Center; Medicine, Section of Pulmonary
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Medical Research Institute
🇪🇬Alexandria, Egypt
Mansoura University Hospital
🇪🇬Dakahlia, Egypt
University Clinic Centre Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
🇷🇺Ufa, Russian Federation
Highlands Oncology Group
🇺🇸Rogers, Arkansas, United States
University Clinical Center of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
Gharbia Cancer Society
🇪🇬Tanta, Egypt
St. Petersburg SHI "City Clinical Oncology Dispensary"
🇷🇺Saint-Petersburg, Russian Federation
National Cancer Institute
🇪🇬Cairo, Egypt
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
🇨🇦Montreal, Quebec, Canada
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
University of Washington Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University General Hospital of Heraklion
🇬🇷Crete, Greece
Institut Gustave Roussy
🇫🇷Villejuif, France
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
🇩🇪Mainz, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
ðŸ‡ðŸ‡ºDebrecen, Hungary
Orszagos Onkologiai Intezet
ðŸ‡ðŸ‡ºBudapest, Hungary
Pecsi Tudomanyegyetem
ðŸ‡ðŸ‡ºPecs, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
ðŸ‡ðŸ‡ºBudapest, Hungary
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
🇮🇹Milano, Lombardia, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
🇮🇱Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
🇷🇺Kazan, Russian Federation
Auckland City Hospital
🇳🇿Auckland, New Zealand
Christchurch Clinical Studies Trust
🇳🇿Christchurch, New Zealand
IPO de Lisboa; Servico de Oncologia Medica
🇵🇹Lisboa, Portugal
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement
🇷🇺Moskva, Moskovskaja Oblast, Russian Federation
IPO do Porto; Servico de Oncologia Medica
🇵🇹Porto, Portugal
Medisprof SRL
🇷🇴Cluj-Napoca, Romania
SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2
🇷🇺Krasnodar, Russian Federation
Moscow city oncology hospital #62 of Moscow Healthcare Department
🇷🇺Moscow, Russian Federation
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
🇿🇦Parktown, Johannesburg, South Africa
Clinical Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
Cape Town Oncology Trials
🇿🇦Cape Town, South Africa
Cancercare Langenhoven Drive Oncology Centre
🇿🇦Port Elizabeth, South Africa
Hospital Regional Universitario de Malaga; Oncologia
🇪🇸Málaga, Malaga, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, LA Coruña, 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 ClÃnico 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
Churchill Hospital
🇬🇧Oxford, United Kingdom
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Instituto Valenciano Oncologia; Oncologia Medica
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Royal Marsden Hospital
🇬🇧Surrey, United Kingdom
Universitätsklinikum Wurzburg
🇩🇪Würzburg, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of