NCT02739360

Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Terminated Phase 4 Results posted Last updated 4 March 2020

What this trial tests

Phase 4 trial testing Idelalisib in Lymphoid Malignancies in 3 participants. Terminated before completion.

Timeline

4 May 2016

Primary endpoint
28 December 2017

28 December 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	4 May 2016
Primary completion	28 December 2017
Estimated completion	28 December 2017
Sites	1 location across Netherlands

Drugs / interventions tested

• Idelalisib — full drug profile →

Conditions studied

• Lymphoid Malignancies — all drugs for Lymphoid Malignancies →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Lymphoid Malignancies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths Primary · 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.

≥ Grade 3 Adverse Event

Group	Value	95% CI
Idelalisib	1

SAE

Group	Value	95% CI
Idelalisib	1

Death

Group	Value	95% CI
Idelalisib	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 602 plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Idelalisib

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (2 terms)

Reaction	System	Idelalisib
Cholangitis	Hepatobiliary disorders	—
Lung disorder	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (22 terms — click to expand)

Reaction	System	Idelalisib
Urinary tract infection	Infections and infestations	—
Anaemia	Blood and lymphatic system disorders	—
Vision blurred	Eye disorders	—
Abdominal distension	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Fatigue	General disorders	—
Influenza like illness	General disorders	—
Oedema peripheral	General disorders	—
Pyrexia	General disorders	—
Aspartate aminotransferase increased	Investigations	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Dizziness	Nervous system disorders	—
Neuralgia	Nervous system disorders	—
Delirium	Psychiatric disorders	—
Renal impairment	Renal and urinary disorders	—
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	—
Skin ulcer	Skin and subcutaneous tissue disorders	—
Intermittent claudication	Vascular disorders	—

Most-reported serious reactions: Cholangitis, Lung disorder.

Data from ClinicalTrials.gov NCT02739360 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inhibitors of the PI3K/AKT/mTOR pathway in human malignancies; trend of current clinical trials.
   Davoodi-Moghaddam Z, Jafari-Raddani F, Delshad M, Pourbagheri-Sigaroodi A, et al · · 2023 · cited 14× · PMID 37594532 · DOI 10.1007/s00432-023-05277-x
2. IDO1 correlates with the immune landscape of head and neck squamous cell carcinoma: a study based on bioinformatics analyses.
   Gkountana GV, Wang L, Giacomini M, Hyytiäinen A, et al · · 2024 · cited 5× · PMID 38736462 · DOI 10.3389/froh.2024.1335648