A Phase 2 interventional study of Osteodex in Prostate Cancer Metastatic, sponsored by DexTech Medical AB. Completed at 8 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by DexTech Medical AB · Phase 2, Interventional, and Treatment
This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.
The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).
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, height, body temperature and respiratory rate are measured. Blood samples are drawn and urine sample is collected. ECG is recorded. Bone scan and diagnostic CT scan are also 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 recorded, blood samples drawn and urine sample collected. FACT-P and EQ-5D-5L (European Quality of Life - 5 Dimensions with 5 levels) questionnaire are filled out by the subject. Adverse events and concomitant medication is documented and the first dose of the investigational product is given.
The subject is surveyed for 3 hours at the hospital.
The duration of the study for the individual subject will be approximately 20 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive 10 doses of investigational product. After the follow-up visit, the subject enters to long-term follow-up phase which lasts approximately 2 years.
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 the protocol.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 55 is close to the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →DexTech Medical AB is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Laboratory requirements:
Haematology:
Neutrophils ≥ 1.5 x 109/l Haemoglobin ≥ 90 g/l Platelets ≥ 100 x 109/l
Hepatic function:
Total S-bilirubin ≤ 1.5 times the upper limit of normal (ULN) AST (SGOT) / ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN in patients with known liver metastases
Renal function:
S-creatinine (S-Cr)≤ 1.5 times ULN
Exclusion Criteria:
formulation: solution for infusion route of administration: intravenous infusion
Drug: Osteodex
formulation: solution for infusion route of administration: intravenous infusion
Drug: Osteodex
formulation: solution for infusion route of administration: intravenous infusion
Drug: Osteodex
formulation: solution for infusion route of administration: intravenous infusion
Also known as: ODX
Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP).
Time frame: Baseline and 20 weeks of treatment
Progression free survival, defined as the time from study entry to the date of disease progression or death from any cause.
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Overall survival, defined as the time from randomisation to the date of death from any cause.
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at each time point sampled (except 12 weeks).
Time frame: Baseline and 20 weeks of treatment
Change from baseline in response markers related to bone metabolism (Serum C-Terminal Telopeptide (S-CTX) and osteocalcin) at each time point sampled.
Time frame: Baseline and 20 weeks of treatment
Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled.
Time frame: Baseline and 20 weeks of treatment
Time to PSA progression
Time frame: Baseline and 20 weeks of treatment
Time to ALP progression
Time frame: Baseline and 20 weeks of treatment
Time to P1NP progression
Time frame: Baseline and 20 weeks of treatment
Time to progression in bone
Time frame: Baseline and 20 weeks of treatment
Time to progression in soft tissue
Time frame: Baseline and 20 weeks of treatment
Use of analgesics as reported by the patient during treatment and follow-up
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Therapy response based on changes from baseline according to Response Evaluation Criteria In Solid Tumors (RECIST) based on diagnostic CT in patients with measurable soft tissue metastases.
Time frame: Baseline and 20 weeks of treatment
Changes from baseline in bone metastasis by means of bone scan at each time point examined.
Time frame: Baseline and 20 weeks of treatment
Occurrence of symptomatic skeletal events
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Pain (FACT-P questionnaire)
Time frame: Baseline and 20 weeks of treatment
Pain (EQ-5D-5L questionnaire)
Time frame: Baseline and 20 weeks of treatment
Quality of life (EQ-5D-5L questionnaire)
Time frame: Baseline and 20 weeks of treatment
Incidence, causality and intensity of Adverse Events (AEs)
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Dose and duration of medications required for the treatment of AEs
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Plan to share: Undecided
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DexTech Medical AB