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

February 12, 2012
May 29, 2014
May 2012
December 2015   (final data collection date for primary outcome measure)
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.
Overall Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01539291 on ClinicalTrials.gov Archive Site
  • 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.
  • Patient Well-Being (Health related quality of life questionnaires) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease related biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pharmacokinetic to measure peak plasma concentrations (Cmax) as well as the area under the plasma concentration versus time curve (AUC).
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Health Resource Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • 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
  • Active Comparator: High-dose Idelalisib
    Participants will receive idelalisib 300 mg twice daily (600 mg per day).
    Intervention: Drug: Idelalisib
  • Active Comparator: Standard-dose Idelalisib
    Participants will receive idelalisib 150 mg twice daily (300 mg per day) plus placebo to match idelalisib.
    Interventions:
    • Drug: Idelalisib
    • Drug: Idelalisib placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion:

  • Subjects in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
  • Tolerating primary study therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   United Kingdom
 
NCT01539291
GS-US-312-0117, 2011-006293-72
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Thomas Jahn, MD Gilead Sciences
Gilead Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP