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NCT01306643 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01306643: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01306643 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01306643, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.
Primary Outcome
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Interventions
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01306643 record still lists
NCT01306643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Idelalisib is the first listed.
NCT01306643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01306643 about?
NCT01306643 is a clinical study titled "Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma". The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatme...
What is the current status of trial NCT01306643?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01306643?
The interventions under investigation include: Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01306643?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01306643's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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