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

NCT02825628 | Completed Phase 2 DMC

• 1 other identifier: ODX-003
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 8

Brief Summary

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).

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP).

  Baseline and 20 weeks of treatment

Secondary Outcomes (19)

• Progression free survival, defined as the time from study entry to the date of disease progression or death from any cause.

  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.

  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).

  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.

  Baseline and 20 weeks of treatment

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

  Baseline and 20 weeks of treatment

Study Arms (3)

Osteodex 3.0 mg/kg

EXPERIMENTAL

formulation: solution for infusion route of administration: intravenous infusion

Drug: Osteodex

Osteodex 6.0 mg/kg

EXPERIMENTAL

formulation: solution for infusion route of administration: intravenous infusion

Drug: Osteodex

Osteodex 9.0 mg/kg

EXPERIMENTAL

formulation: solution for infusion route of administration: intravenous infusion

Drug: Osteodex

Interventions

Osteodex DRUG

formulation: solution for infusion route of administration: intravenous infusion

Also known as: ODX

Osteodex 3.0 mg/kg; Osteodex 6.0 mg/kg; Osteodex 9.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of signing the informed consent form
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
• 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
• Castrate level of serum testosterone ≤1.7 nmol/L
• Performance status ECOG 0-2
• 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
• No evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin)
• Able to adhere to the study visit schedule and other protocol requirements Life expectancy ≥6 months

You may not qualify if:

• 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.
• Any treatment modalities involving palliative radiation therapy or major surgery within 4 weeks prior to treatment in this study
• 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
• 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
• Known brain metastases
• Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug
• Treatment with bisphosphonates or denosumab within 4 weeks prior to first dose of study medication

Sponsors & Collaborators

• DexTech Medical AB: lead

Study Sites (8)

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Tampere University Hospital, Urology Clinic

Tampere, 33520, Finland

Location

Latgales Urology Center

Daugavpils, 5401, Latvia

Location

Pauls Strandins Clinical University Hospital

Riga, 1002, Latvia

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

Urology Clinic, Sodersjukhuset AB

Stockholm, 118 83, Sweden

Location

Oncology Clinic, Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

Location

Related Publications (1)

• Thellenberg-Karlsson C, Vjaters E, Kase M, Tammela T, Ojamaa K, Norming U, Nyman C, Andersson SO, Hublarovs O, Marquez-Holmberg M, Castellanos E, Ullen A, Holmberg A, Nilsson S. A randomised, double-blind, dose-finding, phase II multicentre study of ODX in the treatment of patients with castration-resistant prostate cancer and skeletal metastases. Eur J Cancer. 2023 Mar;181:198-207. doi: 10.1016/j.ejca.2022.12.006. Epub 2022 Dec 20.

  PMID: 36682096 DERIVED

Study Officials

• Anders Holmberg, MD

  DexTech Medical AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 7, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2020
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

FI (1); SE (3); LA (2); ES (2)