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

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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: GS-1101

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GS-1101; GS-1101 (oral; 150 mg BID)	Drug: GS-1101; 150 mg taken twice daily by mouth; Other Names: CAL-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival		18 mon
Patient Well-Being	Health-related quality-of-life questionnaire	18 months
Disease-related Biomarkers		18 months
Pharmacokinetics	Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)	6 months
Incidence of Adverse Events		18 months
Health Resource Utilization		18 months

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Langdon Miller, MD, Gilead Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Ofatumumab; CLL; Chronic Lymphocytic Leukemia; CAL-101
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Idelalisib
• Other Study ID Numbers: GS-US-312-0120