Prostate Cancer MetastaticPhase 2NCT02378870
A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC
A Phase 2 study testing Osteodex in people with Prostate Cancer Metastatic, run by DexTech Medical AB at 1 site in Sweden.
Trial summary
This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Osteodex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- Failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
- Evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
- Evidence of PSA progression in two consecutive determinations at minimum 1 week interval.
- Castrate level of serum testosterone ≤1.7 nmol/L
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- Performance status ECOG 0-2
- Laboratory requirements: Haematology: Neutrophils ≥ 1.5 x 109/l Hemoglobin ≥ 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 Renal function: S-creatinine ≤ 1.5 times the upper limit of normal (ULN) Electrolytes: S-sodium, S-potassium, S-calcium (S-albumin corrected), S-phosphate, S-magnesium, all within normal ranges.
- 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
Who cannot join
- Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist or polyestradiol phosphate bicalutamide. Washout period bicalutamide 6 weeks; after flutamide 4 weeks; abiraterone / enzalutamide 6 weeks.
- Any treatment modalities involving chemotherapy, radiation 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.
- Plasma glucose level ≥7 mmol/l (or >120 mg/dl) at screening.
- 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 within 4 weeks prior to first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Multicentre Phase II Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine.
The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.
Read the 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 PET-CT 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 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 30 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive at least 7 doses and maximum 13 doses of investigational product.
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
- Being tested
- Osteodex, Placebo
- Keywords
- CRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteodexDrug
Also called ODX
Osteodex 3.0 mg/kg given every two week, maximum 13 times.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A:Osteodex | Experimental | 3.0 mg/kg bodyweight solution for infusion Receives: Drug: Osteodex |
| B: Placebo | Placebo comparator | NaCl 0.9% solution for infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in response markers related to bone metabolism (B-ALP and S-P1NP)
Measured: Baseline and 24 weeks of treatment
Secondary outcomes (11)
Relative change in response markers related to bone metabolism (B-ALP and S-P1NP)
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 weeks of treatment and at 2 weeks post-treatment.
Relative change in response markers related to bone metabolism (S-CTX and osteocalcin)
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
PSA response
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
Overall survival
Life expectancy for participating subjects ≥ 6 months
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Pain
FACT-P questionnaire
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
Analgesic consumption
Life expectancy for participating subjects ≥ 6 months
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Changes in tumor cell metabolism measured
PET-CT
Measured: Baseline, 12 and 24 weeks of treatment
Changes in bone metastasis
Bone scan
Measured: Baseline, 12 and 24 weeks of treatment
Incidence, causality and intensity of AEs
Life expectancy for participating subjects ≥ 6 months
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months
Dose and duration of medications required for the treatment of AEs
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Change from baseline in Quality of life
EQ-5D-5L questionnaire, FACT-P questionnaire
Measured: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and 2 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionSep 2015
Why it stopped: Poor patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexTech Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camilla Thellenberg-Karlsson, MD, PhD., Principal investigator, Oncology Department, Norrland University Hospital (NUS) Umeå SwedenClaes Nyman, MD, PhD., Principal investigator, Urology Clinic, Stockholm South General Hospital (SÖS) Stockholm SwedenHenriette Lindberg, MD, PhD., Principal investigator, Oncology Department, Herlev Hospital, Copenhagen DenmarkAnders R Holmberg, CEO, Study director, DexTech Medical AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378870
- Sponsor's protocol ID
- ODX-002
- Status last verified
- Jun 2016
- First submitted
- 17 Nov 2014
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Multicentre Phase II Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
- ClinicalTrials.gov ID
- NCT02378870
- Acronym / sponsor ID
- ODX-002
- Conditions
- Prostate Cancer Metastatic
- Keywords
- CRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- DexTech Medical ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine.
The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.
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 PET-CT 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 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 30 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive at least 7 doses and maximum 13 doses of investigational product.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A:Osteodex | Experimental | Drug: Osteodex3.0 mg/kg bodyweight solution for infusion |
| B: Placebo | Placebo comparator | Drug: PlaceboNaCl 0.9% solution for infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- Failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
- Evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
- Evidence of PSA progression in two consecutive determinations at minimum 1 week interval.
Key exclusion criteria (8 listed)
- Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist or polyestradiol phosphate bicalutamide. Washout period bicalutamide 6 weeks; after flutamide 4 weeks; abiraterone / enzalutamide 6 weeks.
- Any treatment modalities involving chemotherapy, radiation 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.
- Plasma glucose level ≥7 mmol/l (or >120 mg/dl) at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteodexAlso: ODXOsteodex 3.0 mg/kg given every two week, maximum 13 times. | Drug | A:Osteodex |
| Placebo | Drug | B: Placebo |
Primary outcome
Relative change in response markers related to bone metabolism (B-ALP and S-P1NP)
Time frame: Baseline and 24 weeks of treatment
11 secondary outcomes
Relative change in response markers related to bone metabolism (B-ALP and S-P1NP)
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 weeks of treatment and at 2 weeks post-treatment.
Relative change in response markers related to bone metabolism (S-CTX and osteocalcin)
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
PSA response
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
Overall survival
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Pain
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.
Analgesic consumption
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Changes in tumor cell metabolism measured
Time frame: Baseline, 12 and 24 weeks of treatment
Changes in bone metastasis
Time frame: Baseline, 12 and 24 weeks of treatment
Incidence, causality and intensity of AEs
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months
Dose and duration of medications required for the treatment of AEs
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment. Long-term follow-up will be conducted every 3rd month, up to 12 months.
Change from baseline in Quality of life
Time frame: Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and 2 weeks post-treatment.
Results and safety
The study was stopped early (reason given: Poor patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Thellenberg-Karlsson, MD, PhD. principal investigator
Oncology Department, Norrland University Hospital (NUS) Umeå Sweden
Claes Nyman, MD, PhD. principal investigator
Urology Clinic, Stockholm South General Hospital (SÖS) Stockholm Sweden
Henriette Lindberg, MD, PhD. principal investigator
Oncology Department, Herlev Hospital, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osteodex in people with Prostate Cancer Metastatic, run by DexTech Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in response markers related to bone metabolism (B-ALP and S-P1NP) (time frame: Baseline and 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.