NCT01659047

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

August 3, 2012

Last Update Submit

September 6, 2012

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaCLLCAL-101Ofatumumab

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

GS-1101

EXPERIMENTAL

GS-1101 (oral; 150 mg BID)

Drug: GS-1101

Interventions

GS-1101DRUG

150 mg taken twice daily by mouth

Also known as: CAL-101
GS-1101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Langdon Miller, MD

    Gilead Sciences

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

September 7, 2012

Record last verified: 2012-09