Trial Outcomes & Findings for Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma (NCT NCT01306643)
NCT ID: NCT01306643
Last Updated: 2018-11-19
Results Overview
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
30 days post last study treatment (up to 12 months)
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at 2 study sites in the United States. The first participant was screened on 22 February 2011. The last study visit occurred on 24 August 2015.
24 participants were screened.
Participant milestones
| Measure |
Idelalisib
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Idelalisib
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Other: Change in Eligibility Status
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
Baseline characteristics by cohort
| Measure |
Idelalisib
n=18 Participants
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Diagnosis
Follicular lymphoma
|
10 participants
n=99 Participants
|
|
Diagnosis
Marginal zone lymphoma
|
3 participants
n=99 Participants
|
|
Diagnosis
Small lymphocytic lymphoma
|
4 participants
n=99 Participants
|
|
Diagnosis
Missing
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 days post last study treatment (up to 12 months)Population: Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Outcome measures
| Measure |
Idelalisib
n=18 Participants
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Overall Safety of Idelalisib
Any AE
|
88.9 percentage of participants
|
|
Overall Safety of Idelalisib
Serious AE
|
27.8 percentage of participants
|
|
Overall Safety of Idelalisib
Grade ≥ 3 AE
|
55.6 percentage of participants
|
|
Overall Safety of Idelalisib
AE related to idelalisib
|
83.3 percentage of participants
|
|
Overall Safety of Idelalisib
AE leading to permanent drug discontinuation
|
27.8 percentage of participants
|
PRIMARY outcome
Timeframe: Up to twelve 28-day cycles (maximum of 12 months)Population: ITT Analysis Set
Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12. Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment. * CR was defined as the disappearance of all evidence of disease. * PR was defined the regression of measurable disease and no new sites.
Outcome measures
| Measure |
Idelalisib
n=18 Participants
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Clinical Response: Overall Response Rate
|
44.4 percentage of participants
Interval 21.5 to 69.2
|
SECONDARY outcome
Timeframe: Up to twelve 28-day cycles (maximum of 12 months)Population: Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to twelve 28-day cycles (maximum of 12 months)Population: Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to twelve 28-day cycles (maximum of 12 months)Population: Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to twelve 28-day cycles (maximum of 12 months)Population: Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib
n=18 participants at risk
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Cellulitis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Transaminases increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Renal failure
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
Other adverse events
| Measure |
Idelalisib
n=18 participants at risk
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Cardiac disorders
Atrial tachycardia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Blepharospasm
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Chalazion
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Conjunctival hyperaemia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Keratitis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Photopsia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
8/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Lip discolouration
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Painful defaecation
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Paraesthesia oral
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Asthenia
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Chest pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Chills
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Fatigue
|
44.4%
8/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Influenza like illness
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Malaise
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Pain
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
General disorders
Pyrexia
|
27.8%
5/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Atypical pneumonia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Candida infection
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Hordeolum
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
4/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
8/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
8/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Blood bilirubin increased
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Blood phosphorus increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Blood uric acid increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Glomerular filtration rate decreased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Hepatic enzyme increased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Neutrophil count decreased
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Transaminases increased
|
22.2%
4/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Investigations
Weight decreased
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Hypersomnia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Lethargy
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Mental impairment
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Neuropathy peripheral
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Nervous system disorders
Sinus headache
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Psychiatric disorders
Agitation
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Psychiatric disorders
Emotional disorder
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Psychiatric disorders
Insomnia
|
27.8%
5/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Chromaturia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Nocturia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Renal and urinary disorders
Renal failure
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
2/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
5/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • 30 days post last study treatment (up to 12 months)
ITT Analysis Set
|
Additional Information
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