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

NCT01306643 | Completed Phase 1 Results

• 1 other identifier: 101-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma

Keywords

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)

Outcome Measures

Primary Outcomes (2)

• Overall Safety of Idelalisib

  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

  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 Outcomes (4)

• Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells

  Up to twelve 28-day cycles (maximum of 12 months)

• Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells

  Up to twelve 28-day cycles (maximum of 12 months)

• Changes in Concentration of Peripheral Blood Chemokines and Cytokines

  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

  Up to twelve 28-day cycles (maximum of 12 months)

Study Arms (1)

Idelalisib

EXPERIMENTAL

Drug: Idelalisib

Interventions

Idelalisib DRUG

Tablet(s) administered orally twice daily

Also known as: GS-1101, CAL-101, Zydelig®

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (2)

Stanford Cancer Center

Palo Alto, California, 94304-5548, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 2, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 19, 2018
• Results First Posted: December 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (2)