A Phase I Study to Evaluate the Safety and Tolerability, of the Aminopeptidase Inhibitor, CHR-2797, in Patients With Advanced Tumours

Chroma Therapeutics0 sites41 target enrollmentOctober 2004

ConditionsAdvanced Solid Tumors

DrugsCHR-2797 (tosedostat)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumors
Sponsor: Chroma Therapeutics
Enrollment: 41
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

March 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chroma Therapeutics

Eligibility Criteria

Inclusion Criteria

•Signed, informed consent
•Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists
•Evaluable disease
•Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy)
•Adequate bone marrow, hepatic and renal function including the following:
•Hb ≥ 9.0 g/dl, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100x109/L
•Total bilirubin ≤ 1.5 x upper normal limit
•AST and ALT ≤ 2.5 x upper normal limit (or ≤ 5 x UNL in the presence of liver metastases)
•Creatinine ≤1.5 x upper normal limit
•Age \< 18 years

Exclusion Criteria

•Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). In patients with progressive disease (PD), continuation of LHRH agonists for prostate cancer, bisphosphonates for bone disease and corticosteroids was permitted provided the dose was stable before and during the study
•Co-existing active infection or serious concurrent illness
•Significant cardiovascular disease as defined by
•History of congestive heart failure requiring therapy
•History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
•Presence of severe valvular heart disease
•Presence of a ventricular arrhythmia requiring treatment
•Any co-existing medical condition that in the Investigator's judgement substantially increased the risk associated with the patient's participation in the study
•Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
•Gastrointestinal disorders that might have interfered with absorption of the study drug

Outcomes

Primary Outcomes

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.

Time Frame: 3 years

Secondary Outcomes

To determine the PK parameters for oral CHR-2797 at increasing dose levels;(3 years)
To investigate the PD effects of CHR-2797 in blood and tumour cells(3 years)
To enable a preliminary assessment of anti-tumour activity of CHR-2797(3 years)