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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.

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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

FieldValue
Enrollment Target 18 participants
Start Date 2011-02
Est. Completion 2015-08
Phase Phase 1

Sponsor

Gilead Sciences

504 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.