A double-blind, multi-centre phase II dose finding study of ODX (Osteodex) in for patients with castration resistant prostate cancer and skeletal metastates

Phase 1

• Conditions: Metastatic Castration Resistant Prostate Cancer (CRPC) and skeletal metastases; MedDRA version: 19.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005666-37-SE
• Lead Sponsor: DexTech Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-23
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

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
4. Evidence of PSA progression in three consecutive determinations at minimum 1 week intervals
5. Castrate level of serum testosterone =1.7 nmol/L
6. Performance status ECOG 0-2
7. 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
8. No evidence (= 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin)
9. Able to adhere to the study visit schedule and other protocol requirements
10. Life expectancy =6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified