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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 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 18 participants.
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.
Interventions
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01306643
The ClinicalTrials.gov registry entry for NCT01306643 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Idelalisib is the first listed.
NCT01306643 reports 0 study locations.
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.
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