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

NCT ID: NCT02825628

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-06-30

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).

Detailed Description

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.

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Osteodex 3.0 mg/kg

formulation: solution for infusion route of administration: intravenous infusion

Group Type: EXPERIMENTAL

Osteodex

Intervention Type: DRUG

formulation: solution for infusion route of administration: intravenous infusion

Osteodex 6.0 mg/kg

formulation: solution for infusion route of administration: intravenous infusion

Group Type: EXPERIMENTAL

Osteodex

Intervention Type: DRUG

formulation: solution for infusion route of administration: intravenous infusion

Osteodex 9.0 mg/kg

formulation: solution for infusion route of administration: intravenous infusion

Group Type: EXPERIMENTAL

Osteodex

Intervention Type: DRUG

formulation: solution for infusion route of administration: intravenous infusion

Interventions

Osteodex

formulation: solution for infusion route of administration: intravenous infusion

Intervention Type: DRUG

Other Intervention Names

ODX

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

DexTech Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Holmberg, MD

Role: STUDY_DIRECTOR

DexTech Medical AB

Locations

East Tallinn Central Hospital

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Tampere University Hospital, Urology Clinic

Tampere, , Finland

Latgales Urology Center

Daugavpils, , Latvia

Pauls Strandins Clinical University Hospital

Riga, , Latvia

Örebro University Hospital

Örebro, , Sweden

Urology Clinic, Sodersjukhuset AB

Stockholm, , Sweden

Oncology Clinic, Norrlands Universitetssjukhus

Umeå, , Sweden

Countries

Estonia; Finland; Latvia; Sweden

References

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.

Reference Type: DERIVED

PMID: 36682096 (View on PubMed)

Other Identifiers

ODX-003

Identifier Type: -

Identifier Source: org_study_id