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Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Adults With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT02242045
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Indolent Non-Hodgkin Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia) Marginal Zone Lymphoma Drug: Idelalisib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : December 25, 2014
Actual Study Completion Date : October 17, 2017


Arm Intervention/treatment
Experimental: Idelalisib
- Idelalisib cohort: Idelalisib 150 mg in participants with iNHL or CLL
Drug: Idelalisib
Tablet (s) administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101




Primary Outcome Measures :
  1. Type, frequency, severity, timing, and relationship to idelalisib of adverse events (AEs), abnormal laboratory tests, and drug discontinuations due to AEs and serious adverse events (SAEs) [ Time Frame: Up to 28 days ]
    This composite endpoint will measure the overall safety of idelalisib after 28 days of exposure.

  2. PK profile of idelalisib and its major metabolite GS-563117 [ Time Frame: Predose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose on Days 1 and 29 ]

    This composite endpoint will measure the plasma PK profile of idelalisib and GS-563117. The following PK parameters will be measured on Days 1 and 29, where applicable:

    • Cmax: maximum observed concentration of drug in plasma
    • Tmax: time of Cmax
    • AUC: concentration of drug over time (area under the plasma concentration versus time curve)

  3. Idelalisib trough and peak plasma concentrations [ Time Frame: Predose and 1.5 hours postdose on Days 8, 15, and 22 ]

Secondary Outcome Measures :
  1. Type, frequency, severity, timing, and relationship to idelalisib of AEs, abnormal laboratory tests, and drug discontinuations due to AEs and SAEs [ Time Frame: Up to 2 years ]
    This composite endpoint will measure the overall safety profile of idelalisib beyond 28 days of exposure.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects with mature B-cell malignancies of indolent non-Hodgkin lymphoma including follicular lymphoma, small lymphocytic lymphoma, lymphoplastic lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia 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 subjects 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242045


Locations
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Japan
Miyagi, Japan
Nagoya, Japan
Sendai, Japan
Tokyo, Japan
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02242045     History of Changes
Other Study ID Numbers: GS-US-313-1380
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Idelalisib
Lymphoma
Leukemia
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell, Marginal Zone
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action