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Completed

NCT Number: 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)

The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Indolent Non-hodgkin Lymphoma Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia) Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participants with mature B-cell malignancies of iNHL including follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and CLL by World Health Organization classification
  • Must have been born in Japan and must not have lived outside of Japan for > 1 year in the 5 years prior to Day 1
  • Must be able to trace maternal and paternal ancestry of parents and grandparents as Japanese
  • Must have been previously treated with at least 1 regimen for iNHL or CLL and currently require treatment
  • Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Required baseline laboratory data (within 4 weeks prior to Day 1)
  • A negative serum pregnancy test for female participants of childbearing potential
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's disease.

Key Exclusion Criteria:

  • Known histological transformation to an aggressive histology
  • Known presence of myelodysplastic syndrome
  • History of iNHL or CLL with central nervous system involvement
  • Life expectancy < 120 days as per investigator assessment
  • History of a nonlymphoid malignancy with the following exceptions:
  • the malignancy has been in remission without treatment for ≥ 5 years prior to Day 1, or
  • carcinoma in situ of the cervix, or
  • adequately treated basal or squamous cell skin cancer or other localized nonmelanoma skin cancer, or
  • surgically treated low-grade prostate cancer, or
  • ductal carcinoma in situ of the breast treated with lumpectomy alone
  • On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
  • History or diagnosis of pneumonitis or interstitial lung disease.
  • On-going inflammatory bowel disease
  • Pregnancy or breastfeeding
  • History of prior allogeneic hematopoietic stem cell or solid organ transplantation
  • Concurrent participation in another therapeutic clinical trial
  • Prior or on-going clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

idelalisib

Drug

150 mg tablet(s) administered orally twice daily

Other names: Zydelig®, GS-1101, CAL-101

Primary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure

    Time frame: 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.

  2. Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure

    Time frame: 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.

  3. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline

    Time frame: 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.

  4. Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure

    Time frame: 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.

  5. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1

    Time frame: 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.

  6. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8

    Time frame: Predose and 1.5 hours postdose on Day 8

  7. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15

    Time frame: Predose and 1.5 hours postdose on Day 15

  8. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22

    Time frame: Predose and 1.5 hours postdose on Day 22

  9. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29

Secondary outcomes

  1. Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure

    Time frame: 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.

  2. Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure

    Time frame: 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.

  3. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline

    Time frame: First dose date up to 30 days after last dose (up to approximately 3 years)

    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per CTCAE, Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.

  4. Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 1b Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Subjects With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Sep 16, 2014
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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