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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoid Malignancies

Thank you

Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Type, frequency and severity of adverse events

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HGS1029-C1080

NCT ID:

NCT01013818

Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Lymphoid Malignancies
  • Neoplasms

Name

Location

Mayo Clinic Rochester, Minnesota  55905
Hackensack University Medical Center Hackensack, New Jersey  07601