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

NCT02378870 | Terminated Phase 2 DMC

• 1 other identifier: ODX-002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Metastatic

Keywords

CRPC

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 24 weeks of treatment

Secondary Outcomes (11)

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

  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)

  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

  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

  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

  Baseline and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks of treatment and at 2 weeks post-treatment.

Study Arms (2)

A:Osteodex

EXPERIMENTAL

3.0 mg/kg bodyweight solution for infusion

Drug: Osteodex

B: Placebo

PLACEBO COMPARATOR

NaCl 0.9% solution for infusion

Drug: Placebo

Interventions

Osteodex DRUG

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

Also known as: ODX

A:Osteodex

Placebo DRUG

B: Placebo

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 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

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 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.

Sponsors & Collaborators

• DexTech Medical AB: lead

Study Sites (1)

Oncology clinic, Norrlands Universitetssjukhus

Umeå, Umeå, 901 85, Sweden

Location

Study Officials

• Camilla Thellenberg-Karlsson, MD, PhD.

  Oncology Department, Norrland University Hospital (NUS) Umeå Sweden

  PRINCIPAL INVESTIGATOR

• Claes Nyman, MD, PhD.

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

  PRINCIPAL INVESTIGATOR

• Henriette Lindberg, MD, PhD.

  Oncology Department, Herlev Hospital, Copenhagen Denmark

  PRINCIPAL INVESTIGATOR

• Anders R Holmberg, CEO

  DexTech Medical AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: March 4, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

SE (1)