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

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ClinicalTrials.gov Identifier: NCT02825628
Recruitment Status : Unknown
Verified February 2019 by DexTech Medical AB.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
DexTech Medical AB

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP). [ Time Frame: Baseline and 20 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled. [ Time Frame: Baseline and 20 weeks of treatment ]
  • Time to PSA progression [ Time Frame: Baseline and 20 weeks of treatment ]
  • Time to ALP progression [ Time Frame: Baseline and 20 weeks of treatment ]
  • Time to P1NP progression [ Time Frame: Baseline and 20 weeks of treatment ]
  • Time to progression in bone [ Time Frame: Baseline and 20 weeks of treatment ]
  • Time to progression in soft tissue [ 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 ]
  • 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 ]
  • Changes from baseline in bone metastasis by means of bone scan at each time point examined. [ 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 ]
  • Pain (FACT-P questionnaire) [ Time Frame: Baseline and 20 weeks of treatment ]
  • Pain (EQ-5D-5L questionnaire) [ Time Frame: Baseline and 20 weeks of treatment ]
  • Quality of life (EQ-5D-5L questionnaire) [ 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer Metastatic
Intervention  ICMJE Drug: Osteodex
formulation: solution for infusion route of administration: intravenous infusion
Other Name: ODX
Study Arms  ICMJE
  • Experimental: Osteodex 3.0 mg/kg
    formulation: solution for infusion route of administration: intravenous infusion
    Intervention: Drug: Osteodex
  • Experimental: Osteodex 6.0 mg/kg
    formulation: solution for infusion route of administration: intravenous infusion
    Intervention: Drug: Osteodex
  • Experimental: Osteodex 9.0 mg/kg
    formulation: solution for infusion route of administration: intravenous infusion
    Intervention: Drug: Osteodex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 25, 2018)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2016)
60
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Finland,   Latvia,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825628
Other Study ID Numbers  ICMJE ODX-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party DexTech Medical AB
Study Sponsor  ICMJE DexTech Medical AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anders Holmberg, MD DexTech Medical AB
PRS Account DexTech Medical AB
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP