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

This study is currently recruiting participants.
Verified March 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01539291
First received: February 12, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

A companion study to 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
 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) as Therapy for Patients With Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-dose Idelalisib Drug: Idelalisib
Idelalisib 300mg taken twice daily by mouth
Other Names:
  • GS-1101
  • CAL 101
Active Comparator: Standard-dose Idelalisib Drug: Idelalisib
Idelalisib 150mg taken twice daily by mouth
Other Names:
  • GS-1101
  • CAL 101

Detailed Description:

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; in this study, compliant subjects from GS-US-312-0116 who are tolerating primary study therapy but experience CLL progression are eligible to receive active Idelalisib therapy.

  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
  • Have definitive progression of CLL while receiving primary study drug therapy (Idelalisib/placebo).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539291

Contacts
Contact: Maria Aiello 206-256-4927 Maria.Aiello@gilead.com

  Show 52 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
Study First Received: February 12, 2012
Last Updated: March 18, 2013
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 May 19, 2013