Clinical Trials Directory

Trials / Terminated

TerminatedNCT00101244

SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin's or Non-Hodgkin's Lymphoma

A Phase I, Open-Label, Dose-Escalation Study of SB-715992 Administered Days 1-3 of a 21-Day Cycle in Patients With Solid Tumors

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
31 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of SB-715992 administered as a 1-hr intravenous infusion on days 1-3 of a 21-day cycle in patients with solid tumors. II. To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of SB-715992 for this administration schedule. SECONDARY OBJECTIVES: I. To observe clinical response of SB-715992 given days 1-3, every 21-days. II. To characterize the pharmacokinetics (PK) of SB-715992 for this administration schedule. III. To explore drug metabolism, molecular and cellular predictors of efficacy (biomarkers) and toxicity and drug interaction potential. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SB-715992 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at the MTD Patients are followed for 4 weeks. PROJECTED ACCRUAL: A total of 18-31 patients will be accrued for this study within 11-19 months.

Conditions

Interventions

TypeNameDescription
DRUGispinesibGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2004-11-01
Primary completion
2010-02-01
First posted
2005-01-10
Last updated
2013-01-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00101244. Inclusion in this directory is not an endorsement.