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NCT01739764 · ClinicalTrials.gov registry record · Phase 4
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, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 215
- Enrollment target
NCT01739764 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 215 participants.
The verdict
NCT01739764, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 215 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2013-02-19 |
| Est. Completion | 2020-02-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01739764
The ClinicalTrials.gov registry entry for NCT01739764 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vemurafenib is the first listed.
NCT01739764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01739764 about?
NCT01739764 is a clinical study titled "An Extension (Rollover) Study of Vemurafenib in Participants 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 progr...
What is the current status of trial NCT01739764?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 215 participants. The study started on 2013-02-19. Estimated completion is 2020-02-17.
What interventions are being tested in trial NCT01739764?
The interventions under investigation include: Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01739764?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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