Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01306643
First received: February 25, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

This Phase 1/2, open-label, single-arm, efficacy, safety, and pharmacodynamic study is to evaluate safety and efficacy of idelalisib (GS-1101, CAL-101) in patients with previously treated indolent non-Hodgkin lymphoma (iNHL).

Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Drug: Idelalisib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-agent CAL-101 for Previously Teated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Evaluate the overall safety of idelalisib [ Time Frame: Every 2-4 weeks ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by assessing extent of exposure to idelalisib, adverse events, clinical laboratory data, and vital signs

  • Clinical response rate during treatment with idelalisib based on standard criteria [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Flow cytometric measurement of phosphorylation of Akt and S6 within the tumor B cells [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Flow cytometric measurement of tumoral and peripheral blood T and NK cells [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Changes in concentration of peripheral blood chemokines and cytokines [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Changes in liver imaging as assessed by MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib Drug: Idelalisib
Idelalisib tables 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Previously treated low-grade (indolent) B-cell NHL
  • Measurable disease by CT scan, defined as at least 2 lesions that measure > 1.5 cm in a single dimension (one of which is superficial and easily accessible for biopsy)
  • WHO performance status of ≤ 2
  • For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug
  • History of a transplant with current active graft-versus-host-disease
  • Known active central nervous system involvement of the malignancy
  • Active, serious infection requiring systemic therapy
  • Positive test for HIV antibodies
  • Active hepatitis B or C viral infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306643

Locations
United States, California
Stanford Cancer Center Active, not recruiting
Palo Alto, California, United States, 94304-5548
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Joshua Brody, MD       Joshua.brody@mssm.edu   
Principal Investigator: Joshua Brody, MD         
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Joshua Brody, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01306643     History of Changes
Other Study ID Numbers: 101-10
Study First Received: February 25, 2011
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Indolent Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
iNHL
NHL
CAL-101
PI3K
Phosphatidylinositol 3-kinase
Follicular Lymphoma (FL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014