Back to results

A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

Primary Purpose

Prostate Cancer Metastatic

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Osteodex

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.
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 levels 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

Renal function:

S-Cr ≤ 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.

Exclusion Criteria:

Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist, polyestradiol phosphate, bicalutamide, flutamide or cyproterone is allowed.
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.
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, Skånes Universitetssjukhus i Lund
Urology clinic, Södersjukhuset AB
Oncology clinic, Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Osteodex, infusion

Arm Description

Osteodex

Outcomes

Primary Outcome Measures

To define the maximum tolerable dose (MTD) of Osteodex.

The MTD will be defined as the dose that is a predecessor to the dose where dose limiting toxicity (DLT, e.g., lack of recovery to baseline of serum creatinine (S-Cr), clinically significant abnormalities in test results for haematology, liver function, electrolytes, calcium, clinically significant ECG changes) occurs within 3 weeks after administration for at least 1 among 4 subjects. In case such dose limiting toxicity (DLT) is not observed for any doses the maximum dose at 1.5 mg/kg will be defined as the MTD.

Secondary Outcome Measures

Evaluation of overall survival

PSA response

Response markers related to bone metabolism (S-ALP and U-NTx)

Quality of Life

FACT-P questionnaire

Assessment of blood half life

Full Information

NCT ID

NCT01595087

First Posted

May 8, 2012

Last Updated

November 12, 2014

Sponsor

DexTech Medical AB

1. Study Identification

Unique Protocol Identification Number

NCT01595087

Brief Title

A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

Official Title

A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

September 2013 (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 I/IIa study is a multi-center, prospective, open-label study evaluating safety and biological efficacy of up to six dose levels 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 define the maximum tolerable dose of Osteodex when given every third week. The following objectives will also be evaluated: overall survival, PSA response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and assessment of pharmacokinetic parameters.

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, body temperature and respiratory rate are measured. Blood samples are drawn and urine sample is collected. ECG is 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 performed, blood samples drawn and urine sample collected. FACT-P questionnaire is filled out by the subject. Adverse events and concomitant medication is documented and the first dose of the investigational product is given. The subject will be consecutively assigned to the dose cohorts, starting with the lowest dose cohort, cohort one out of seven cohorts. Then the subject is surveyed during 24 hours at the hospital. Prior to discharge from the hospital the same examinations are done as described above. The duration of the study for the individual subject will be approximately 25 weeks from screening to the follow-up visit 3 weeks after the last dose. Each subject will receive at least 4 doses and maximum 7 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 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Osteodex, infusion

Arm Type

Experimental

Arm Description

Osteodex

Intervention Type

Drug

Intervention Name(s)

Osteodex

Other Intervention Name(s)

Castration resistant prostate cancer

Intervention Description

Seven cohorts; Dose cohort 1; 0.1 mg/kg given every third week, maximum 7 times. Dose cohort 2; 0.3 mg/kg given every third week, maximum 7 times. Dose cohort 3; 0.6 mg/kg given every third week, maximum 7 times. Dose cohort 4; 0.9 mg/kg given every third week, maximum 7 times. Dose cohort 5; 1.2 mg/kg given every third week, maximum 7 times. Dose cohort 6; 1.5 mg/kg given every third week, maximum 7 times. Dose cohort 7; 3.0 mg/kg given every third week, maximum 7 times.

Primary Outcome Measure Information:

Title

To define the maximum tolerable dose (MTD) of Osteodex.

Description

Time Frame

up to 21 weeks

Secondary Outcome Measure Information:

Title

Evaluation of overall survival

Time Frame

Baseline and 21 weeks

Title

PSA response

Time Frame

Baseline and 21 weeks

Title

Response markers related to bone metabolism (S-ALP and U-NTx)

Time Frame

Baseline and 21 weeks

Title

Quality of Life

Description

FACT-P questionnaire

Time Frame

Baseline and 21 weeks

Title

Assessment of blood half life

Time Frame

pre-infusion and 30 min, 1 hr, 2 hrs, 3 hrs and 6 hrs post infusion

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. 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 levels 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 Renal function: S-Cr ≤ 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. Exclusion Criteria: Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist, polyestradiol phosphate, bicalutamide, flutamide or cyproterone is allowed. 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. 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

Anders R Holmberg, CEO

Organizational Affiliation

DexTech Medical AB

Official's Role

Study Director

Facility Information:

Facility Name

Oncology clinic, Skånes Universitetssjukhus i Lund

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Urology clinic, Södersjukhuset 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

12. IPD Sharing Statement

Learn more about this trial

A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

We'll reach out to this number within 24 hrs