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

October 19, 2018 updated by: Gilead Sciences

Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-5548
        • Stanford Cancer Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously treated relapsed or refractory B-cell iNHL
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Active, serious infection requiring systemic therapy
  • Positive test for HIV antibodies
  • Active hepatitis B or C viral infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Idelalisib
Drug: Idelalisib
Tablet(s) administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Safety of Idelalisib
Time Frame: 30 days post last study treatment (up to 12 months)
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
30 days post last study treatment (up to 12 months)
Clinical Response: Overall Response Rate
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)

Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.

Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.

  • CR was defined as the disappearance of all evidence of disease.
  • PR was defined the regression of measurable disease and no new sites.
Up to twelve 28-day cycles (maximum of 12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)
Up to twelve 28-day cycles (maximum of 12 months)
Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)
Up to twelve 28-day cycles (maximum of 12 months)
Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)
Up to twelve 28-day cycles (maximum of 12 months)
Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)
Up to twelve 28-day cycles (maximum of 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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