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

Primary Purpose

Prostate Cancer Metastatic

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Osteodex
Sponsored by
DexTech Medical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • East Tallinn Central Hospital
  • Tartu University Hospital
  • Tampere University Hospital, Urology Clinic
  • Latgales Urology Center
  • Pauls Strandins Clinical University Hospital
  • Urology Clinic, Sodersjukhuset AB
  • Oncology Clinic, Norrlands Universitetssjukhus
  • Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Osteodex 3.0 mg/kg

Osteodex 6.0 mg/kg

Osteodex 9.0 mg/kg

Arm Description

formulation: solution for infusion route of administration: intravenous infusion

formulation: solution for infusion route of administration: intravenous infusion

formulation: solution for infusion route of administration: intravenous infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression free survival, defined as the time from study entry to the date of disease progression or death from any cause.
Overall survival, defined as the time from randomisation to the date of death from any cause.
Change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at each time point sampled (except 12 weeks).
Change from baseline in response markers related to bone metabolism (Serum C-Terminal Telopeptide (S-CTX) and osteocalcin) at each time point sampled.
Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled.
Time to PSA progression
Time to ALP progression
Time to P1NP progression
Time to progression in bone
Time to progression in soft tissue
Use of analgesics as reported by the patient during treatment and follow-up
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.
Changes from baseline in bone metastasis by means of bone scan at each time point examined.
Occurrence of symptomatic skeletal events
Pain (FACT-P questionnaire)
Pain (EQ-5D-5L questionnaire)
Quality of life (EQ-5D-5L questionnaire)
Incidence, causality and intensity of Adverse Events (AEs)
Dose and duration of medications required for the treatment of AEs

Full Information

First Posted
June 27, 2016
Last Updated
February 12, 2019
Sponsor
DexTech Medical AB
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1. Study Identification

Unique Protocol Identification Number
NCT02825628
Brief Title
Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
Acronym
CRPC
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DexTech Medical AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteodex 3.0 mg/kg
Arm Type
Experimental
Arm Description
formulation: solution for infusion route of administration: intravenous infusion
Arm Title
Osteodex 6.0 mg/kg
Arm Type
Experimental
Arm Description
formulation: solution for infusion route of administration: intravenous infusion
Arm Title
Osteodex 9.0 mg/kg
Arm Type
Experimental
Arm Description
formulation: solution for infusion route of administration: intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Osteodex
Other Intervention Name(s)
ODX
Intervention Description
formulation: solution for infusion route of administration: intravenous infusion
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled.
Time Frame
Baseline and 20 weeks of treatment
Title
Time to PSA progression
Time Frame
Baseline and 20 weeks of treatment
Title
Time to ALP progression
Time Frame
Baseline and 20 weeks of treatment
Title
Time to P1NP progression
Time Frame
Baseline and 20 weeks of treatment
Title
Time to progression in bone
Time Frame
Baseline and 20 weeks of treatment
Title
Time to progression in soft tissue
Time Frame
Baseline and 20 weeks of treatment
Title
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
Title
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
Title
Changes from baseline in bone metastasis by means of bone scan at each time point examined.
Time Frame
Baseline and 20 weeks of treatment
Title
Occurrence of symptomatic skeletal events
Time Frame
Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Title
Pain (FACT-P questionnaire)
Time Frame
Baseline and 20 weeks of treatment
Title
Pain (EQ-5D-5L questionnaire)
Time Frame
Baseline and 20 weeks of treatment
Title
Quality of life (EQ-5D-5L questionnaire)
Time Frame
Baseline and 20 weeks of treatment
Title
Incidence, causality and intensity of Adverse Events (AEs)
Time Frame
Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Holmberg, MD
Organizational Affiliation
DexTech Medical AB
Official's Role
Study Director
Facility Information:
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Tampere University Hospital, Urology Clinic
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Latgales Urology Center
City
Daugavpils
ZIP/Postal Code
5401
Country
Latvia
Facility Name
Pauls Strandins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Urology Clinic, Sodersjukhuset AB
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Oncology Clinic, Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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