NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)

Sponsor

Kiadis Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00248404

Collaborator

(none)

155

Enrollment

Locations

51.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tumors	Drug: NB1011	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Safety/tolerability of NB1011 infusions []
Determination of maximum tolerated dose (MTD) []

Secondary Outcome Measures

Pharmacokinetics of NB1011 and its metabolite []
Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria []
Assessment of TS overexpression []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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