Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01539291
First received: February 12, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension study that is a companion study to Study GS-US-312-0116, to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Idelalisib
Drug: Idelalisib placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall Safety [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Overall safety profile of each study treatment regimen will be characterized by the type, frequency, severity, timing of onset, duration, and relationship to study therapy of any adverse events or abnormalities of laboratory tests, serious adverse events, or adverse events leading to discontinuation of study drug.


Secondary Outcome Measures:
  • Tumor Control [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Tumor control will be assessed by progression-free survival, overall response rate, lymph node response rate, complete response rate, time to response, duration of response, percent change in lymph node area, splenomegaly response rate, hepatomegaly response rate, absolute lymphocyte count (ALC) response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.

  • Patient Well-Being [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Patient well-being will be assessed by overall survival, change from baseline in health-related quality of life (HRQL) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Leukemia (FACT-Leu), and changes from baseline in Karnofsky performance status.

  • Pharmacodynamic [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Pharmacodynamics will be assessed by changes from baseline in phosphatidylinositol 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway activation and changes from baseline in the plasma concentrations of disease-associated chemokines and cytokines.


Estimated Enrollment: 160
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-dose Idelalisib
Participants will receive idelalisib 300 mg twice daily (600 mg per day).
Drug: Idelalisib
Idelalisib 300 mg or 150 mg tablets administered orally
Other Names:
  • GS-1101
  • CAL 101
Active Comparator: Standard-dose Idelalisib
Participants will receive idelalisib 150 mg twice daily (300 mg per day) plus placebo to match idelalisib.
Drug: Idelalisib
Idelalisib 300 mg or 150 mg tablets administered orally
Other Names:
  • GS-1101
  • CAL 101
Drug: Idelalisib placebo
Placebo to match idelalisib administered orally

  Eligibility

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

Inclusion:

  • Subjects in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
  • Tolerating primary study therapy
  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: NCT01539291

  Show 66 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thomas Jahn, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01539291     History of Changes
Other Study ID Numbers: GS-US-312-0117, 2011-006293-72
Study First Received: February 12, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
CAL-101
CAL 101
GS-1101
GS 1101
PI3K
Leukemia
GS-US-312-0116
idelalisib

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

ClinicalTrials.gov processed this record on July 29, 2014