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

This study has been completed.
Sponsor:
Information provided by:
Kiadis Pharma
ClinicalTrials.gov Identifier:
NCT00248404
First received: November 3, 2005
Last updated: September 26, 2012
Last verified: January 2008
  Purpose

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 Intervention Phase
Tumors
Drug: NB1011
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kiadis Pharma:

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

Estimated Enrollment: 155
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248404

Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 30033
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Kiadis Pharma
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00248404     History of Changes
Obsolete Identifiers: NCT00255736
Other Study ID Numbers: CR-TSC-001
Study First Received: November 3, 2005
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Kiadis Pharma:
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

ClinicalTrials.gov processed this record on October 02, 2014