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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248404
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : September 27, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Tumors Drug: NB1011 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2005

Primary Outcome Measures :
  1. Safety/tolerability of NB1011 infusions
  2. Determination of maximum tolerated dose (MTD)

Secondary Outcome Measures :
  1. Pharmacokinetics of NB1011 and its metabolite
  2. Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  3. Assessment of TS overexpression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248404

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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
Publications of Results:
Pegram M, Yeon CH, Ku N, Gottlieb C, Sheppard M, Cossum P, John E, Iqbal S, Garcia A, Lenz HJ. Enzyme Catalyzed Therapeutic Activation of NB1011 Selectively Targets Thymidylate Synthase-overexpressing Tumor Cells: Phase I Results. ASCO Meeting, New Orleans, June 4-8, 2004 (abstract 3144)

Other Publications:
Layout table for additonal information Identifier: NCT00248404    
Obsolete Identifiers: NCT00255736
Other Study ID Numbers: CR-TSC-001
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: January 2008
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