A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
18 Years
N/A
Male
Prostate Cancer Metastatic
Trial Information
A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To define the maximum tolerable dose (MTD) of Osteodex.
Outcome Description:
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.
Outcome Time Frame:
up to 21 weeks
Safety Issue:
No
Principal Investigator
Anders R Holmberg, CEO
Investigator Role:
Study Director
Investigator Affiliation:
DexTech Medical AB
Authority:
Sweden: Medical Products Agency
Study ID:
ODX-001
NCT ID:
NCT01595087
Start Date:
January 2012
Completion Date:
September 2013
Related Keywords:
- Prostate Cancer Metastatic
- CRPC
- Prostatic Neoplasms
- Neoplasms
- Neoplasms, Second Primary
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