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A Open Label, Dose Escalating Study to Evaluate the Safety and Tolerability of Ascending Intravenous (i.v.) Doses of Catumaxomab in Epithelial Cancer Patients

NCT01320020 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-07-02

No results posted yet for this study

Summary

The study is designed as an open-label dose-escalation study to investigate the safety and tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4 single i.v. administrations of catumaxomab followed by 1 week for safety observations after each administration. All patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first.

Conditions

  • Epithelial Cancer Patients

Interventions

DRUG

catumaxomab

Inter patient dose escalation 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, MD · Vall d'Hebron University Hospital, Barcelona, Spain

  • Christian Dittrich, Prim.Univ.-Prof. · Zentrum für Onkologie und Hämatologie, Kaiser Franz Josef-Spital, Wien, Austria

  • Morten Sorenesen, MD, Ph.D. · The Finsen Center, Department of Oncology, Rigshospitalet, Copenhagen, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Austria
  • Denmark
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320020 on ClinicalTrials.gov