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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01739764




Registration number
NCT01739764
Ethics application status
Date submitted
26/11/2012
Date registered
3/12/2012
Date last updated
7/01/2021

Titles & IDs
Public title
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Scientific title
An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Secondary ID [1] 0 0
2012-003144-80
Secondary ID [2] 0 0
GO28399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vemurafenib

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: Vemurafenib
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Intensity of Vemurafenib
Timepoint [1] 0 0
Baseline up to a maximum of 7 years.
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2020
Sample size
Target
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
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United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
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United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
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Belarus
State/province [10] 0 0
Minsk District
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Bosnia and Herzegovina
State/province [12] 0 0
Banja Luka
Country [13] 0 0
Bosnia and Herzegovina
State/province [13] 0 0
Sarajevo
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Croatia
State/province [16] 0 0
Zagreb
Country [17] 0 0
Cyprus
State/province [17] 0 0
Nicosia
Country [18] 0 0
Egypt
State/province [18] 0 0
Alexandria
Country [19] 0 0
Egypt
State/province [19] 0 0
Cairo
Country [20] 0 0
Egypt
State/province [20] 0 0
Dakahlia
Country [21] 0 0
Egypt
State/province [21] 0 0
Tanta
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Villejuif
Country [24] 0 0
Germany
State/province [24] 0 0
Heidelberg
Country [25] 0 0
Germany
State/province [25] 0 0
Mainz
Country [26] 0 0
Germany
State/province [26] 0 0
Würzburg
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Greece
State/province [27] 0 0
Crete
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Debrecen
Country [30] 0 0
Hungary
State/province [30] 0 0
Pecs
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Israel
State/province [33] 0 0
Ramat Gan
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Aviv
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
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Italy
State/province [36] 0 0
Toscana
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Korea, Republic of
State/province [37] 0 0
Daegu
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Korea, Republic of
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Seoul
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Netherlands
State/province [39] 0 0
Maastricht
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Portugal
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Lisboa
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Portugal
State/province [43] 0 0
Porto
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Romania
State/province [44] 0 0
Cluj-Napoca
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Moskovskaja Oblast
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Kazan
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Krasnodar
Country [48] 0 0
Russian Federation
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Moscow
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Russian Federation
State/province [49] 0 0
Saint-Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Ufa
Country [51] 0 0
Serbia
State/province [51] 0 0
Belgrade
Country [52] 0 0
South Africa
State/province [52] 0 0
Cape Town
Country [53] 0 0
South Africa
State/province [53] 0 0
Parktown, Johannesburg
Country [54] 0 0
South Africa
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Port Elizabeth
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Spain
State/province [55] 0 0
Cantabria
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
State/province [58] 0 0
Malaga
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Spain
State/province [59] 0 0
Murcia
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Salamanca
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Oxford
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01739764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01739764