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A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC

Primary Purpose

Prostate Cancer Metastatic

Status

Terminated

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Osteodex

Placebo

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring CRPC

Eligibility Criteria

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

Inclusion Criteria:

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
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

Exclusion Criteria:

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.

Sites / Locations

Oncology clinic, Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A:Osteodex

B: Placebo

Arm Description

3.0 mg/kg bodyweight solution for infusion

NaCl 0.9% solution for infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Relative change in response markers related to bone metabolism (S-CTX and osteocalcin)

PSA response

Overall survival

Life expectancy for participating subjects ≥ 6 months

Pain

FACT-P questionnaire

Analgesic consumption

Life expectancy for participating subjects ≥ 6 months

Changes in tumor cell metabolism measured

PET-CT

Changes in bone metastasis

Bone scan

Incidence, causality and intensity of AEs

Life expectancy for participating subjects ≥ 6 months

Dose and duration of medications required for the treatment of AEs

Change from baseline in Quality of life

EQ-5D-5L questionnaire, FACT-P questionnaire

Full Information

NCT ID

NCT02378870

First Posted

November 17, 2014

Last Updated

June 29, 2016

Sponsor

DexTech Medical AB

1. Study Identification

Unique Protocol Identification Number

NCT02378870

Brief Title

A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Poor patient recruitment

Study Start Date

January 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

September 2015 (Actual)

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 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.

6. Conditions and Keywords

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

Prostate Cancer Metastatic

Keywords

CRPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A:Osteodex

Arm Type

Experimental

Arm Description

3.0 mg/kg bodyweight solution for infusion

Arm Title

B: Placebo

Arm Type

Placebo Comparator

Arm Description

NaCl 0.9% solution for infusion

Intervention Type

Drug

Intervention Name(s)

Osteodex

Other Intervention Name(s)

ODX

Intervention Description

Osteodex 3.0 mg/kg given every two week, maximum 13 times.

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and 24 weeks of treatment

Secondary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

Overall survival

Description

Life expectancy for participating subjects ≥ 6 months

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.

Title

Pain

Description

FACT-P questionnaire

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.

Title

Analgesic consumption

Description

Life expectancy for participating subjects ≥ 6 months

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.

Title

Changes in tumor cell metabolism measured

Description

PET-CT

Time Frame

Baseline, 12 and 24 weeks of treatment

Title

Changes in bone metastasis

Description

Bone scan

Time Frame

Baseline, 12 and 24 weeks of treatment

Title

Incidence, causality and intensity of AEs

Description

Life expectancy for participating subjects ≥ 6 months

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

Title

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.

Title

Change from baseline in Quality of life

Description

EQ-5D-5L questionnaire, FACT-P questionnaire

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. 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 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camilla Thellenberg-Karlsson, MD, PhD.

Organizational Affiliation

Oncology Department, Norrland University Hospital (NUS) Umeå Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Claes Nyman, MD, PhD.

Organizational Affiliation

Urology Clinic, Stockholm South General Hospital (SÖS) Stockholm Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henriette Lindberg, MD, PhD.

Organizational Affiliation

Oncology Department, Herlev Hospital, Copenhagen Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anders R Holmberg, CEO

Organizational Affiliation

DexTech Medical AB

Official's Role

Study Director

Facility Information:

Facility Name

Oncology clinic, Norrlands Universitetssjukhus

City

Umeå

ZIP/Postal Code

901 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC

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