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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739764
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : November 18, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, multicenter, non-randomized study will provide 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 are treated beyond progression and are still deriving clinical benefit (as assessed by investigator), and may therefore potentially benefit from continued treatment with vemurafenib. Participants will receive 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 will continue until progression of disease or as long as the participant is 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 occurs first.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Vemurafenib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 19, 2013
Actual Primary Completion Date : February 17, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vemurafenib

Arm Intervention/treatment
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.
Drug: Vemurafenib
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Other Name: Zelboraf

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.
Drug: Vemurafenib
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Other Name: Zelboraf

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.
Drug: Vemurafenib
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Other Name: Zelboraf




Primary Outcome Measures :
  1. Dose Intensity of Vemurafenib [ Time Frame: 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 :
  1. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739764


Locations
Show Show 83 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01739764    
Other Study ID Numbers: GO28399
2012-003144-80 ( EudraCT Number )
First Posted: December 3, 2012    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Vemurafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action