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NCT01870726 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01870726: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01870726 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01870726, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The study assessed the safety and the dose of the combination of INC280 and buparlisib (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In addition, the anti-tumor activity of INC280 single agent should have been assessed in patients with recurrent glioblastoma with c-Met alteration.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment (28 days) with INC280 in combination with buparlisib and meets any of the pre-defined criteria. The maximum tolerated dose was identified as INC280 300 mg BID + buparlisib 80 mg QD.
Interventions
- DRUG Buparlisib
- DRUG INC280
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-01-09 |
| Est. Completion | 2016-12-23 |
| Phase | Phase 1 |
Why NCT01870726 stopped before completion
NCT01870726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Buparlisib is the first listed.
NCT01870726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01870726 about?
NCT01870726 is a clinical study titled "Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma". The study assessed the safety and the dose of the combination of INC280 and buparlisib (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In addition, the anti-tumor activi...
What is the current status of trial NCT01870726?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2014-01-09. Estimated completion is 2016-12-23.
What interventions are being tested in trial NCT01870726?
The interventions under investigation include: Buparlisib (DRUG), INC280 (DRUG).
Who is sponsoring clinical trial NCT01870726?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01870726's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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