A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01659047
First received: August 3, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: GS-1101
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 18 mon ] [ Designated as safety issue: No ]
  • Patient Well-Being [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Health-related quality-of-life questionnaire

  • Disease-related Biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)

  • Incidence of Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Health Resource Utilization [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-1101
GS-1101 (oral; 150 mg BID)
Drug: GS-1101
150 mg taken twice daily by mouth
Other Name: CAL-101

Detailed Description:

This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.

This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

  Eligibility

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

Inclusion Criteria:

  • Participation in Study GS-US-312-0119
  • Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119.
  • Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
  • The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.
  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: NCT01659047

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Langdon Miller, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01659047     History of Changes
Other Study ID Numbers: GS-US-312-0120
Study First Received: August 3, 2012
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Chronic Lymphocytic Leukemia
CLL
CAL-101
Ofatumumab

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 August 20, 2014