Status:
COMPLETED
NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)
Lead Sponsor:
Kiadis Pharma
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, brea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2007
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00248404
Start Date
September 1 2005
End Date
December 12 2007
Last Update
May 16 2022
Active Locations (3)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 30033
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9