Trial Outcomes & Findings for Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820 (NCT NCT02739360)

Last Updated: 2020-03-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Up to Day 602 plus 30 days

Results posted on

2020-03-04

Participant Flow

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.

Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.

Participant milestones

Participant milestones
Measure	Idelalisib Idelalisib 150 mg tablet administered orally twice daily.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Idelalisib Idelalisib 150 mg tablet administered orally twice daily.
Overall Study Adverse Event	1
Overall Study Study terminated by Sponsor	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Idelalisib n=3 Participants Idelalisib 150 mg tablet administered orally twice daily.
Age, Customized From 65 - 84 years	3 Participants n=3 Participants
Sex: Female, Male Female	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to Day 602 plus 30 days

Population: Safety Analysis Set: participants who took at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Idelalisib n=3 Participants Idelalisib 150 mg tablet administered orally twice daily.
Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths ≥ Grade 3 Adverse Event	1 Participants
Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths SAE	1 Participants
Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths Death	0 Participants

Adverse Events

Idelalisib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Idelalisib n=3 participants at risk Idelalisib 150 mg tablet administered orally twice daily.
Hepatobiliary disorders Cholangitis	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Idelalisib n=3 participants at risk Idelalisib 150 mg tablet administered orally twice daily.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Eye disorders Vision blurred	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Gastrointestinal disorders Constipation	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
General disorders Fatigue	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
General disorders Influenza like illness	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
General disorders Oedema peripheral	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
General disorders Pyrexia	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Infections and infestations Urinary tract infection	100.0% 3/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Nervous system disorders Dizziness	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Nervous system disorders Neuralgia	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Psychiatric disorders Delirium	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Renal and urinary disorders Renal impairment	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.
Vascular disorders Intermittent claudication	33.3% 1/3 • Up to Day 602 plus 30 days Safety Analysis Set: participants who took at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER