An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
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|ClinicalTrials.gov Identifier: NCT01739764|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2012
Last Update Posted : November 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Vemurafenib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 24, 2020|
Participants will receive oral vemurafenib at 960 mg BID, 720 mg BID, or 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 will be given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Other Name: Zelboraf
- Percentage of Participants With Continued Access to Vemurafenib [ Time Frame: Baseline up to approximately 6 years ]
- Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 6 years ]
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
|Study Director:||Clinical Trials||Hoffmann-La Roche|