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Safety and Anti-Disease Activity of CHR-2797 (Tosedostat) in Elderly and/or Treatment Refractory Patients With Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM)

NCT00689000 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2010-10-22

No results posted yet for this study

Summary

This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases:

* Phase I: an open-label, dose-escalating phase of the study to explore the safety, tolerability, and pharmacokinetics (PK) of CHR-2797.
* Phase II: the recommended dose level of CHR-2797, as determined in phase I, will be administered to a further cohort of approximately 40 patients to determine whether CHR-2797 has sufficient biological activity against the disease(s) under study.

Conditions

Interventions

DRUG

CHR-2797 (tosedostat): Aminopeptidase inhibitor

Phase I: Once daily, oral ingestion of CHR-2797 capsules (60mg, 90mg, 130mg or 180mg) depending on cohort Phase II: Once daily, oral ingestion of 130mg CHR-2797 (recommended dose from Phase I) until progressive disease or withdrawal from the study

Sponsors & Collaborators

  • Chroma Therapeutics

    lead INDUSTRY

Principal Investigators

  • Gareth Morgan, MD · Royal Marsden Hospital, UK

  • Gert Ossenkoppele, MD · Vrije Universiteit MC, Amsterdam

  • Pierre Zachée, MD · ZNA Antwerpen, Belgium

  • Alan Burnett, MD · University Hospital, Cardiff, United Kingdom

  • Michel Delforge, MD · UZ Gasthuisberg, Leuven, Belgium

  • Bob Lowenberg, MD · Erasmus MC, Rotterdam

  • Ulrich Dührsen, MD · Universitätsklinikum, Essen, Germany

  • Carsten Müller-Tidow, MD · Universitätsklinikum, Münster, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT00689000 on ClinicalTrials.gov