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drugset / Trial / NCT00692354

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

NCT00692354 ↗

Phase 1 Completed 41 enrolled Chroma Therapeutics Institute of Cancer Research, United Kingdom · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-10
Primary completion
2007-11
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tosedostat Small molecule 10 mg Oral
Subject Tosedostat Small molecule 20 mg Oral
Subject Tosedostat Small molecule 40 mg Oral
Subject Tosedostat Small molecule 90 mg Oral
Subject Tosedostat Small molecule 130 mg Oral
Subject Tosedostat Small molecule 180 mg Oral
Subject Tosedostat Small molecule 240 mg Oral
Subject Tosedostat Small molecule 320 mg Oral

Indications

cancer