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Sponsors and Collaborators: |
Chroma Therapeutics Institute of Cancer Research, United Kingdom |
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Information provided by: | Chroma Therapeutics |
ClinicalTrials.gov Identifier: | NCT00692354 |
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:
Condition | Intervention | Phase |
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Advanced Solid Tumors |
Drug: CHR-2797 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study to Evaluate the Safety and Tolerability, of the Aminopeptidase Inhibitor, CHR-2797, in Patients With Advanced Tumours |
Enrollment: | 41 |
Study Start Date: | October 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, hepatic and renal function including the following:
Exclusion Criteria:
Significant cardiovascular disease as defined by
Responsible Party: | Chroma Therapeutics Ltd ( Dr Leon Hooftman ) |
Study ID Numbers: | CHR-2797-001 |
Study First Received: | June 4, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00692354 |
Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Advanced Solid Tumour Tumor Oral |