A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
Males, diagnosed with CRPC, who fulfil the inclusion criteria and does not have any
exclusion criteria, will be asked to participate in the study. The subject will be informed
orally and in writing about the study procedures and give written informed consent, prior to
study start. At the screening visit the following examinations are performed: Physical
examination, medical history and concomitant medication. Heart rate, blood pressure, weight,
body temperature and respiratory rate are measured. Blood samples are drawn and urine sample
is collected. ECG is performed. At the next visit, baseline, the subject is examined
physically and heart rate, blood pressure, weight, body temperature and respiratory rate are
measured, ECG is performed, blood samples drawn and urine sample collected. FACT-P
questionnaire is filled out by the subject. Adverse events and concomitant medication is
documented and the first dose of the investigational product is given. The subject will be
consecutively assigned to the dose cohorts, starting with the lowest dose cohort, cohort one
out of seven cohorts.
Then the subject is surveyed during 24 hours at the hospital. Prior to discharge from the
hospital the same examinations are done as described above.
The duration of the study for the individual subject will be approximately 25 weeks from
screening to the follow-up visit 3 weeks after the last dose. Each subject will receive at
least 4 doses and maximum 7 doses of investigational product.
A Data Monitoring Committee (DMC) will be designated and will be responsible to
monitor/review all study related safety data. After review of safety data the DMC will
provide recommendation as to whether the dose escalation can proceed as planned according to
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the maximum tolerable dose (MTD) of Osteodex.
The MTD will be defined as the dose that is a predecessor to the dose where dose limiting toxicity (DLT, e.g., lack of recovery to baseline of serum creatinine (S-Cr), clinically significant abnormalities in test results for haematology, liver function, electrolytes, calcium, clinically significant ECG changes) occurs within 3 weeks after administration for at least 1 among 4 subjects. In case such dose limiting toxicity (DLT) is not observed for any doses the maximum dose at 1.5 mg/kg will be defined as the MTD.
up to 21 weeks
Anders R Holmberg, CEO
DexTech Medical AB
Sweden: Medical Products Agency