Study Stopped
Terminated due to slow accrual
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
1 other identifier
interventional
11
2 countries
5
Brief Summary
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2009
Typical duration for phase_1
5 active sites
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 2, 2013
August 1, 2013
2 years
November 3, 2009
August 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Type, frequency and severity of adverse events
1 year
Secondary Outcomes (3)
Measure pharmacokinetic profile
1st two months of the study
Evaluation of pharmacodynamics
1st two months of the study
Evaluation of possible anti-tumor activity
Every 2 months while on study
Study Arms (1)
HGS1029
EXPERIMENTALInterventions
HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.
Eligibility Criteria
You may qualify if:
- Confirmed relapsed/refractory lymphoid malignancies
- Previously treated with at least 2 therapeutic regimens
- ECOG performance \< 2.
- Life expectancy of at least 3 months
- Adequate renal function
- Adequate hematologic status
- Adequate liver function
- Transfusion independent
You may not qualify if:
- Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
- The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
- Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
- Known HIV infection
- Positive for hepatitis B surface antigen or positive hepatitis C antibody
- Grade 2 or greater neuropathy
- Pregnant female or nursing mother
- Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Oxford Cancer and Haematology Centre
Headington, Oxford, OX3 7LJ, United Kingdom
The Institute of Cancer Research
Belmont, Sutton, Surrey, SM2 5NG, United Kingdom
Cancer Research UK Centre
Southampton, SO16 6YD, United Kingdom
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 16, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 2, 2013
Record last verified: 2013-08