NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)
Phase 1
Completed
- Conditions
- Tumors
- Registration Number
- NCT00248404
- Lead Sponsor
- Kiadis Pharma
- 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, breast, and lung cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety/tolerability of NB1011 infusions Determination of maximum tolerated dose (MTD)
- Secondary Outcome Measures
Name Time Method Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Pharmacokinetics of NB1011 and its metabolite Assessment of TS overexpression
Trial Locations
- Locations (3)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States