CompletedPhase 1 / Phase 2NCT00248404
Official study title

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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNB1011

The study team can explain what participation involves.

Who it may be forTumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 16, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Kiadis Pharma

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Kiadis Pharma
Interventions being studied
Drug: NB1011
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USC Norris Comprehensive Cancer CenterLos Angeles, California
  • University of MinnesotaMinneapolis, Minnesota
  • Princess Margaret HospitalToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 16, 2022. Always confirm current availability with the study team.

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