NeoplasmsPhase 4NCT01739764
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
A Phase 4 study testing Vemurafenib in people with Neoplasms, run by Hoffmann-La Roche at 83 sites in 25 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Vemurafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 83 sitesin 25 countries
- Study dates
- 19 Feb 2013to 17 Feb 2020
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
83 sites in 25 countries.
83 sites in 25 countries
Spain16 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, 15006
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital General Universitario Santa Lucia
Cartagena (Murcia), Murcia, 30202
Hospital Universitario La Paz
Madrid, 280146
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
Hospital Regional Universitario de Malaga; Oncologia
Málaga, Malaga, 29010
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008
Hospital Universitario Virgen Macarena
Seville, 41009
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009
Hospital General Universitario de Valencia
Valencia, 46014
United States12 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
University of Chicago Medical Center; Medicine, Section of Pulmonary
Chicago, Illinois, 60637
Mary Crowley Medical Research Center; Oncology
Dallas, Texas, 75246
UCLA Department of Medicine
Los Angeles, California, 90024
New York University Medical Center PRIME
New York, New York, 10016
Evelyn H. Lauder Center
New York, New York, 10065
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Highlands Oncology Group
Rogers, Arkansas, 72758
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center
Sioux City, Iowa, 51108
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
M D Anderson Physician Network
Webster, Texas, 77598
Russia6 sites
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', 420029
SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2
Krasnodar, 350040
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, 143423
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement
Moskva, Moscow Oblast, 115478
St. Petersburg SHI "City Clinical Oncology Dispensary"
Saint Petersburg, 197022
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, 450054
Hungary5 sites
Semmelweis Egyetem
Budapest, 1083
Orszagos Onkologiai Intezet
Budapest, 1122
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, H-1077
Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
Debrecen, 4012
Pecsi Tudomanyegyetem
Pécs, 7624
South Korea5 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Samsung Medical Center
Seoul, (0)6351
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Egypt4 sites
Medical Research Institute
Alexandria, 21131
National Cancer Institute
Cairo, 11796
Mansoura University Hospital
Dakahlia, 324
Gharbia Cancer Society
Tanta
Israel4 sites
Rambam Health Care Campus
Haifa, 3109600
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
Ramat Gan, 5266202
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Germany3 sites
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
Mainz, 55131
Universitätsklinikum Wurzburg
Würzburg, 97080
South Africa3 sites
Cape Town Oncology Trials
Cape Town, 7570
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, 2193
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, 6045
United Kingdom3 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Churchill Hospital
Oxford, OX3 7LJ
Royal Marsden Hospital
Surrey, SM2 5PT
Bosnia and Herzegovina2 sites
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
University Clinic Centre Sarajevo
Sarajevo, 71000
Croatia2 sites
Clinical Hospital Center Sestre Milosrdnice
Zagreb, 10000
Clinical Hospital Centre Zagreb
Zagreb, 10000
France2 sites
Centre Léon Bérard
Lyon, 69373
Institut Gustave Roussy
Villejuif, 94805
Italy2 sites
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Christchurch Clinical Studies Trust
Christchurch, 8011
Portugal2 sites
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, 1099-023
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072
Serbia2 sites
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, 11000
Clinical Center Bezanijska Kosa
Belgrade, 11070
Belarus1 site
N.N. Alexandrov National Cancer Centre of Belarus
Minsk District, 223040
Canada1 site
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6229 HX
About this study
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
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
- Being tested
- Vemurafenib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemurafenibDrug
Also called Zelboraf
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to a maximum of 7 years.
Secondary outcomes (1)
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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).
Measured: Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study start19 Feb 2013
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739764
- Sponsor's protocol ID
- GO28399
- Other IDs
- 2012-003144-80
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2012
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No