Skip to main content
OpenTrials
Completed

NCT Number: NCT00248404

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tumors Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NB1011

Drug

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

Sponsors and collaborators

Lead sponsor

Kiadis Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 4, 2005
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.