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NCT01090414 · ClinicalTrials.gov registry record · Phase 1
An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 202
- Enrollment target
NCT01090414: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT01090414 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 202 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (237% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01090414, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 202 participants
- Enrollment target
Study Summary
This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
Primary Outcome
Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).
Interventions
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2010-03-22 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 1 |
Why NCT01090414 stopped before completion
NCT01090414 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (237% higher).
The record links to 0 conditions, and to 1 intervention - of which Idelalisib is the first listed.
NCT01090414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01090414 about?
NCT01090414 is a clinical study titled "An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study". This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed a...
What is the current status of trial NCT01090414?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 202 participants. The study started on 2010-03-22. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT01090414?
The interventions under investigation include: Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01090414?
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 NCT01090414's enrollment target sits among peer trials
202 258th of 2000 higher than 1,743 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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