Clinical trial · Interventional
Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
NCT02739360CI-TRIAL-00043805terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idelalisib | Drug | Idelalisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Idelalisib
- description
- Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.
- interventionNames
- Drug: Idelalisib
Primary outcomes (1)
- measure
- Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths
- timeFrame
- Up to Day 602 plus 30 days
- description
- The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit * Evidence of a personally signed informed consent Key Exclusion Criteria: * Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib * Toxicities that would preclude initiating therapy with idelalisib prior to enrollment * Concurrent participation in another therapeutic clinical trial * Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days. Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.