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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595087
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
DexTech Medical AB

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: Osteodex Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Osteodex, infusion
Drug: Osteodex
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.
Other Name: Castration resistant prostate cancer

Primary Outcome Measures :
  1. To define the maximum tolerable dose (MTD) of Osteodex. [ Time Frame: up to 21 weeks ]
    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 :
  1. Evaluation of overall survival [ Time Frame: Baseline and 21 weeks ]
  2. PSA response [ Time Frame: Baseline and 21 weeks ]
  3. Response markers related to bone metabolism (S-ALP and U-NTx) [ Time Frame: Baseline and 21 weeks ]
  4. Quality of Life [ Time Frame: Baseline and 21 weeks ]
    FACT-P questionnaire

  5. Assessment of blood half life [ Time Frame: pre-infusion and 30 min, 1 hr, 2 hrs, 3 hrs and 6 hrs post infusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595087

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Oncology clinic, Skånes Universitetssjukhus i Lund
Lund, Sweden, 221 85
Urology clinic, Södersjukhuset AB
Stockholm, Sweden, 118 83
Oncology clinic, Norrlands Universitetssjukhus
Umeå, Sweden, 901 85
Sponsors and Collaborators
DexTech Medical AB
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Study Director: Anders R Holmberg, CEO DexTech Medical AB
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Responsible Party: DexTech Medical AB Identifier: NCT01595087    
Other Study ID Numbers: ODX-001
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by DexTech Medical AB:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases