A Phase I/II Study of NB1011 Administered Intravenously by Continuous Infusion in an Every Second Week Regimen With Open-label Continuation in Cancers That Overexpress the Enzyme Thymidylate Synthase
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Tumors
Both
Tumors
Trial Information
A Phase I/II Study of NB1011 Administered Intravenously by Continuous Infusion in an Every Second Week Regimen With Open-label Continuation in Cancers That Overexpress the Enzyme Thymidylate Synthase
Inclusion Criteria:
- Advanced, recurrent, or metastatic solid tumors
- TS overexpression (> 4 by reverse transcription polymerase chain reaction [RT-PCR])
in archival and fresh samples
- Suitable for experimental monotherapy
- Measurable disease
Exclusion Criteria:
- Tumors that cannot be biopsied or with low level of TS expression
- Requirement for concomitant anticancer therapy
- Treatment with another investigational product within 30 days of study entry
- Pregnant or lactating women
- Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
- HIV infection
- Clinically apparent meningeal or central nervous system (CNS) metastases or
carcinomatous meningitis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety/tolerability of NB1011 infusions
Authority:
United States: Food and Drug Administration
Study ID:
CR-TSC-001
NCT ID:
NCT00248404
Start Date:
September 2005
Completion Date:
Related Keywords:
- Tumors
- colorectal cancer
- ovarian cancer
- lung cancer
- breast cancer
- small bowel cancer
- Advanced, recurrent, or metastatic solid tumors of any type
- TS overexpression confirmed by fresh biopsy (RTPCR)
- Suitable for experimental monotherapy
Name | Location |
|---|---|
| University of Minnesota | Minneapolis, Minnesota 55455 |
| USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
