Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02825628
• Date of registration: 27/06/2016
• Prospective Registration: No
• Primary sponsor: DexTech Medical AB
• Public title: Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC) CRPC
• Scientific title: A 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
• Date of first enrolment: May 2016
• Target sample size: 55
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02825628
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Estonia, Finland, Latvia, Sweden

Contacts

• Name: Anders Holmberg, MD
• Affiliation: DexTech Medical AB

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 years at the time of signing the informed consent form

2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate

3. Evidence of disease progression based on changes in metastatic bone disease (=2 bone
lesions compared to a prior examination) in bone scan and/or other imaging modality
AND/OR evidence of PSA progression in the three consecutive determinations at minimum
of 1 week intervals

4. Castrate level of serum testosterone =1.7 nmol/L

5. Performance status ECOG 0-2

6. 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

7. No evidence (= 5 years) of prior malignancies (except successfully treated basal cell
or squamous cell carcinoma of the skin)

8. Able to adhere to the study visit schedule and other protocol requirements Life
expectancy =6 months

Exclusion Criteria:

1. Concurrent use of other anti-cancer agents or treatments, with the following
exception: a stable dose of Luteinizing Hormone-Releasing Hormone (LHRH)
agonist/antagonist or polyestradiol phosphate. Washout period: bicalutamide 6 weeks;
flutamide 4 weeks; abiraterone / enzalutamide 6 weeks, chemotherapy 4 weeks;
Radium-223 4 weeks; Strontium-89 or Samarium-153 6 months.

2. Any treatment modalities involving palliative radiation therapy or major surgery
within 4 weeks prior to treatment in this study

3. Simultaneous participation in any other study involving investigational drugs or
having participated in a study less than 4 weeks prior to start of study treatment

4. Any condition, including the presence of laboratory abnormalities, which confounds the
ability to interpret data from the study or places the patient at unacceptable risk if
he participates in the study

5. Known brain metastases

6. Dental surgery (dental extraction), periodontal disease, local trauma including poorly
fitting dentures within 6 months prior to the first dose of study drug

7. Treatment with bisphosphonates or denosumab within 4 weeks prior to first dose of
study medication



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer Metastatic

Intervention(s)

Drug: Osteodex

Primary Outcome(s)

Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP). [Time Frame: Baseline and 20 weeks of treatment]

Secondary Outcome(s)

Time to progression in soft tissue [Time Frame: Baseline and 20 weeks of treatment]

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]

Time to P1NP progression [Time Frame: Baseline and 20 weeks of treatment]

Pain (FACT-P questionnaire) [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]

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]

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]

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]

Incidence, causality and intensity of Adverse Events (AEs) [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]

Pain (EQ-5D-5L questionnaire) [Time Frame: Baseline and 20 weeks of treatment]

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]

Time to ALP progression [Time Frame: Baseline and 20 weeks of treatment]

Quality of life (EQ-5D-5L questionnaire) [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]

Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled. [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]

Time to PSA progression [Time Frame: Baseline and 20 weeks of treatment]

Time to progression in bone [Time Frame: Baseline and 20 weeks of treatment]

Secondary ID(s)

ODX-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors