NCT00248404

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2007

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

November 3, 2005

Last Update Submit

May 10, 2022

Conditions

Tumors

Keywords

colorectal cancerovarian cancerlung cancerbreast cancersmall bowel cancerAdvanced, recurrent, or metastatic solid tumors of any typeTS overexpression confirmed by fresh biopsy (RTPCR)Suitable for experimental monotherapy

Outcome Measures

Primary Outcomes (2)

  • Safety/tolerability of NB1011 infusions

  • Determination of maximum tolerated dose (MTD)

Secondary Outcomes (3)

  • Pharmacokinetics of NB1011 and its metabolite

  • Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  • Assessment of TS overexpression

Interventions

NB1011DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 30033, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (4)

  • 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.

    PMID: 12477050BACKGROUND

  • 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.

    PMID: 10778957BACKGROUND

  • 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.

    PMID: 8558194BACKGROUND

  • 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)

    RESULT

MeSH Terms

Conditions

NeoplasmsColorectal NeoplasmsOvarian NeoplasmsLung NeoplasmsBreast NeoplasmsRecurrence

Interventions

NB1011

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

September 1, 2005

Primary Completion

December 12, 2007

Study Completion

December 12, 2007

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations

CA(1)US(2)