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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01306643
First received: February 25, 2011
Last updated: July 15, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 15, 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, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Lymphoma
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia

ClinicalTrials.gov processed this record on September 22, 2014