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Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours

NCT00692354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2010-08-06

No results posted yet for this study

Summary

The primary objective of this study was to determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.

The secondary objectives of this study were:

* To determine pharmacokinetic parameters for CHR-2797 when administered orally at increasing dose levels;
* To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and, when possible, tumour cells; - To enable a preliminary assessment of anti-tumour activity of CHR-2797.

Conditions

Interventions

DRUG

CHR-2797 (tosedostat)

Drug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Chroma Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-11-30
Completion
2008-03-31

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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 NCT00692354 on ClinicalTrials.gov