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A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer

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Trial Information

A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors

Inclusion Criteria


Inclusion criteria:

- Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor
malignancy that is not responsive to standard therapies or for which there is no
standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma)
that has relapsed or is refractory after prior chemotherapy or radiotherapy and
autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for
which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not
indicated or has been refused by the patient.

- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.

Exclusion criteria:

- Pre-existing hemolytic anemia.

- Pre-existing peripheral neuropathy greater than or equal grade 2.

- Absolute neutrophil count less than 1,500/mm3.

- Platelets less than 100,000/mm3.

- Hemoglobin less than 9 g/dL.

- Total bilirubin greater than1.5 mg/dL.

- AST/ALT greater than 2.5 X upper limit of normal.

- Creatinine clearance less than or equal to 60 mL/min.

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:

Safety and tolerability will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

743921/001

NCT ID:

NCT00136513

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Solid Tumor Cancer
  • Safety
  • tolerability
  • dose limiting toxicity
  • solid tumors
  • Neoplasms

Name

Location

GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SitePittsburgh, Pennsylvania  15213