Trial · NCT02242045
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
NCT02242045, Phase 1, Completed, Gilead Sciences; results first posted 2021-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL). Trials, record NCT02242045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02242045
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
- NCT number
- NCT02242045
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
Chronic Lymphocytic Leukemia, Indolent Non-Hodgkin Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia), Marginal Zone Lymphoma
- Interventions
- Idelalisib
- First posted
- 2014-09-16
- Last updated
- 2021-03-19
- Results first posted
- 2021-03-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Primary | Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | First dose date up to 28 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent.The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. |
| Primary | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Primary | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 | Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both. |
| Primary | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | Predose and 1.5 hours postdose on Day 8 | |
| Primary | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | Predose and 1.5 hours postdose on Day 15 | |
| Primary | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | Predose and 1.5 hours postdose on Day 22 | |
| Primary | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29 | |
| Secondary | Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure | First dose date up to 30 days after last dose (up to approximately 3 years) | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | The Full Analysis Set included all participants who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | First dose date up to 28 days | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 | The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose value reported by the PK laboratory. | ng/mL | MEAN |
| PRIMARY | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | Predose and 1.5 hours postdose on Day 8 | Participants in the PK Analysis Set were analyzed. | ng/mL | MEAN |
| PRIMARY | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | Predose and 1.5 hours postdose on Day 15 | Participants in the PK Analysis Set were analyzed. | ng/mL | MEAN |
| PRIMARY | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | Predose and 1.5 hours postdose on Day 22 | Participants in the PK Analysis Set were analyzed. | ng/mL | MEAN |
| PRIMARY | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29 | Participants in the PK Analysis Set were analyzed. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure | First dose date up to 30 days after last dose (up to approximately 3 years) | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | Idelalisib | TEAEs | 66.7 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | Idelalisib | SAEs | 16.7 | percentage of participants | |
| Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure | Idelalisib | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | Leukocytosis (Grade 1) | 0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | Leukocytosis (Grade 2) | 0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | Leukocytosis (Grade 3) | 16.7 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | Leukocytosis (Grade 4) | 0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | White blood cell decreased (Grade 1) | 16.7 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | White blood cell decreased (Grade 2) | 0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Idelalisib | White blood cell decreased (Grade 3) | 16.7 | percentage of participants |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Idelalisib | 6 | |
| Overall Study | COMPLETED | Idelalisib | 0 | |
| Overall Study | NOT COMPLETED | Idelalisib | 6 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Idelalisib | 1 | 6 | |
| other | Optic disc haemorrhage | Eye disorders | Idelalisib | 1 | 6 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Idelalisib | 1 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Idelalisib | 5 | 6 | |
| other | Gastritis | Gastrointestinal disorders | Idelalisib | 3 | 6 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Idelalisib | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | Idelalisib | 2 | 6 | |
| other | Stomatitis | Gastrointestinal disorders | Idelalisib | 1 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Idelalisib | 1 | 6 | |
| other | Chest pain | General disorders | Idelalisib | 1 | 6 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Idelalisib | 0 | 6 |
| Total, other adverse events | Idelalisib | 6 | 6 |
| Total, serious adverse events | Idelalisib | 5 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32856068 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02242045
GET https://conductscience.org/api/trials/v1/NCT02242045/results?page=2