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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 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 202 participants.
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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.
Interventions
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2010-03-22 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01090414
The ClinicalTrials.gov registry entry for NCT01090414 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 202 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.
NCT01090414 reports 0 study locations.
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.
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