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NCT01658436 · ClinicalTrials.gov registry record · Phase 2
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01658436 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants.
The verdict
NCT01658436, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy. Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study. However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.
Interventions
- DRUG BEZ235 (Stage 1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01658436
The ClinicalTrials.gov registry entry for NCT01658436 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BEZ235 (Stage 1) is the first listed.
NCT01658436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01658436 about?
NCT01658436 is a clinical study titled "BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.". This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy. Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 w...
What is the current status of trial NCT01658436?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2012-11. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01658436?
The interventions under investigation include: BEZ235 (Stage 1) (DRUG).
Who is sponsoring clinical trial NCT01658436?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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