Neoplasm Metastasis
Conditions
Keywords
Metastatic cancer, Disseminated malignant disease
Brief summary
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
Interventions
DRUGimexon
Sponsors
AmpliMed Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously treated malignant disease of any type. * Prior treatment; at least one prior regimen required. * Able to perform the activities of daily living. * Off prior cancer therapy for at least 4 weeks. * If female, neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No other current drug therapy for the cancer. * Blood counts and blood chemistries in or near normal range. * Prior radiation is permitted.
Exclusion criteria
* No active brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximally tolerated dose | — |
| determine the pharmacokinetics | — |
| determine the toxicity of the drug on the designated schedule | — |
Countries
United States
Outcome results
None listed