Lymphoid Malignancies
Conditions
Brief summary
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.
Interventions
DRUGIdelalisib
Idelalisib 150 mg tablet administered orally twice daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | Up to Day 602 plus 30 days | 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. |
Countries
Netherlands
Participant flow
Recruitment details
Participants were enrolled at study sites in the Netherlands. The first participant was screened on 04 May 2016. The last study visit occurred on 28 December 2017.
Pre-assignment details
Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.
Participants by arm
| Arm | Count |
|---|---|
| Idelalisib Idelalisib 150 mg tablet administered orally twice daily. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Study terminated by Sponsor | 2 |
Baseline characteristics
| Characteristic | Idelalisib | — |
|---|---|---|
| Age, Customized From 65 - 84 years | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths
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.
Time frame: Up to Day 602 plus 30 days
Population: Safety Analysis Set: participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Idelalisib | Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | SAE | 1 Participants |
| Idelalisib | Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | ≥ Grade 3 Adverse Event | 1 Participants |
| Idelalisib | Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | Death | 0 Participants |