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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

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
United States, California
University of California, San Diego - Moores Cancer Center
La Jolla, California, United States, 92093
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
UCLA
Santa Monica, California, United States, 90404
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Collaborative Research Group
Boynton Beach, Florida, United States, 33435
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
University of Florida
Gainsville, Florida, United States, 32610
Florida Cancer Specialists
St. Petersburg, Florida, United States, 33705
United States, Georgia
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11042
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Oregon
Willamette Valley Cancer Center
Springfield, Oregon, United States, 97477
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Care Network of South Texas
San Antonio, Texas, United States, 78217
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1024
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
France
Hôpital Henri Mondor
Creteil, France, 94010
CHRU Lille
Lille, France, 59045
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hôpital Pontchaillou
Rennes, France, 35019
Centre Henri Becquerel
Rouen, France, 76038
Hopital Purpan
Toulouse, France, 31059
Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, Germany, 1307
Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker
Erlangen, Germany, 91052
Universitätsklinikum Köln
Köln, Germany, 50937
Universitätsklinikum Ulm
Ulm, Germany, 89081
Italy
Ospedale Oncologico Regionale A. Businco
Cagliari, Italy, 9121
Ospedale San Raffaele S.r.l.
Milano, Italy, 20132
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Castle Hill Hospital
Cottingham, United Kingdom, HU10 6ED
Dorset County Hospital
Dorchester, United Kingdom, DT1 2JY
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Hammersmith Hospital
London, United Kingdom, W12 0NN
King's College Hospital
London, United Kingdom, SE5 9RS
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Freeman Hospital Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Princess Royal University Hospital
Orpington, United Kingdom, BR6 8ND
Salisbury District Hospital
Salisbury, United Kingdom, SP2 8BJ
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Great Western Hospital
Swindon, United Kingdom, SN3 6BB
Torbay District General Hospital
Torquay, United Kingdom, TQ2 7AA
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Yeovil District Hospital
Yeovil, United Kingdom, BA21 4AT
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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014