Solid Tumors
Conditions
Brief summary
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
Interventions
DRUGODM-207
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy * Life expectancy \>12 weeks * Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression * ECOG performance status of 0 to 1
Exclusion criteria
* History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment * Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment) * History of or current leptomeningeal or brain metastasis or spinal cord compression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | 28 days | Highest dose level at which \<33% of patients in a cohort experience Dose Limiting Toxicity (DLT) |
Countries
Finland
Outcome results
None listed