SB-743921 In Patients With Solid Tumors

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00136513
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Patients Per Site: 15

Study Details

Study Description

Brief Summary

The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-743921. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Cancer	Drug: SB-743921	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

1. 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. []

Secondary Outcome Measures

1. Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15232
2	GSK Investigational Site	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, MD, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00136513
• Other Study ID Numbers: 743921/001
• First Posted: Aug 29, 2005
• Last Update Posted: Oct 16, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: Safety; tolerability; dose limiting toxicity; solid tumors
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Oct 16, 2008