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NCT01531894 · ClinicalTrials.gov registry record · Phase 2
Continuation Study of the Oral AKT Inhibitor GSK2110183
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01531894: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01531894 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531894, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.
Primary Outcome
Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
Interventions
- DRUG GSK2110183 (afuresertib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-02-08 |
| Est. Completion | 2018-06-20 |
| Phase | Phase 2 |
What the finished NCT01531894 record still lists
NCT01531894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK2110183 (afuresertib) is the first listed.
NCT01531894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531894 about?
NCT01531894 is a clinical study titled "Continuation Study of the Oral AKT Inhibitor GSK2110183". This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on b...
What is the current status of trial NCT01531894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-02-08. Estimated completion is 2018-06-20.
What interventions are being tested in trial NCT01531894?
The interventions under investigation include: GSK2110183 (afuresertib) (DRUG).
Who is sponsoring clinical trial NCT01531894?
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 NCT01531894's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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