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CompletedNCT00248404Updated May 16, 2022

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

A Phase 1/2 interventional study of NB1011 in Tumors, sponsored by Kiadis Pharma. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Kiadis Pharma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tumors

Keywords

  • 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
03

In context

Lead sponsor

Kiadis Pharma is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (estimated)

Interventions

  • DrugNB1011
06

What researchers measure

Primary outcomes

  1. Safety/tolerability of NB1011 infusions

  2. Determination of maximum tolerated dose (MTD)

Secondary outcomes

  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

07

Study locations

3 sites
  • USC Norris Comprehensive Cancer Center
    Los Angeles, California 30033, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

References and documents

Publications

  • Neuteboom ST, Karjian PL, Boyer CR, Beryt M, Pegram M, Wahl GM, Shepard HM. Inhibition of cell growth by NB1011 requires high thymidylate synthase levels and correlates with p53, p21, bax, and GADD45 induction. Mol Cancer Ther. 2002 Apr;1(6):377-84. PubMed 12477050 ↗
  • Salonga D, Danenberg KD, Johnson M, Metzger R, Groshen S, Tsao-Wei DD, Lenz HJ, Leichman CG, Leichman L, Diasio RB, Danenberg PV. Colorectal tumors responding to 5-fluorouracil have low gene expression levels of dihydropyrimidine dehydrogenase, thymidylate synthase, and thymidine phosphorylase. Clin Cancer Res. 2000 Apr;6(4):1322-7. PubMed 10778957 ↗
  • Lenz HJ, Leichman CG, Danenberg KD, Danenberg PV, Groshen S, Cohen H, Laine L, Crookes P, Silberman H, Baranda J, Garcia Y, Li J, Leichman L. Thymidylate synthase mRNA level in adenocarcinoma of the stomach: a predictor for primary tumor response and overall survival. J Clin Oncol. 1996 Jan;14(1):176-82. doi: 10.1200/JCO.1996.14.1.176. PubMed 8558194 ↗
  • 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)
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00248404
Lead sponsor
Kiadis Pharma
Responsible party
Sponsor
First posted
Nov 4, 2005
Start date
Sep 2005
Primary completion
Dec 12, 2007
Completion
Dec 12, 2007
Last update
May 16, 2022
View the source record on ClinicalTrials.gov ↗

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