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

NCT01595087 | Completed Phase 1 DMC

• 1 other identifier: ODX-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer Metastatic

Keywords

CRPC

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 21 weeks

Secondary Outcomes (5)

• Evaluation of overall survival

  Baseline and 21 weeks

• PSA response

  Baseline and 21 weeks

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

  Baseline and 21 weeks

• Quality of Life

  Baseline and 21 weeks

• Assessment of blood half life

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

Study Arms (1)

Osteodex, infusion

EXPERIMENTAL

Osteodex

Drug: Osteodex

Interventions

Osteodex DRUG

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.

Also known as: Castration resistant prostate cancer

Osteodex, infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DexTech Medical AB: lead

Study Sites (3)

Oncology clinic, Skånes Universitetssjukhus i Lund

Lund, Lund, 221 85, Sweden

Location

Urology clinic, Södersjukhuset AB

Stockholm, Stockholm County, 118 83, Sweden

Location

Oncology clinic, Norrlands Universitetssjukhus

Umeå, Umeå, 901 85, Sweden

Location

Study Officials

• Anders R Holmberg, CEO

  DexTech Medical AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

SE (3)