Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
NCT ID: NCT02654938
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-07-31
2017-09-30
Brief Summary
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Detailed Description
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Patients will be randomised in cohorts of 4 subjects, where 3 subjects will be administered with Mobilan (М-VM3), and one patient will be administered with placebo.
The dose will be escalated from cohort to cohort, the decision on possible dose escalation will be made by Independent Safety Review Board.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mobilan (M-VM3)
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product
Mobilan (M-VM3)
Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.
Placebo
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)
Placebo
5% infusion solution of dextrose
Interventions
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Mobilan (M-VM3)
Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.
Placebo
5% infusion solution of dextrose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Men aged 45 to 75 years
3. Patients with histologically verified prostate cancer, stage Т1-Т2, N0, M0
4. Patient's ECOG status 0-2
5. Negative tests for serologic markers of HIV-infection, viral hepatitis В and С, syphilis Patient and his partner should agree to use barrier contraception throughout the study period
Exclusion Criteria
2. Clinical or radiological signs of metastases
3. Indication to hormone therapy of prostate cancer
4. Clinically significant cardiovascular diseases:
* Myocardial infarction within 6 months prior the screening
* Unstable stenocardia within 3 months prior the screening
* Severe circulation failure (FC III)
* Clinically significant arrhythmias
* Hypotension (systolic blood pressure \< 86 mm Hg) or bradycardia with HR \< 50 beats per min.
* Uncontrolled arterial hypertension (systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg.)
5. Clinically significant CNS diseases at the screening
6. Current infection or another severe or systemic disease which increases risk of treatment sequelae
7. Pituitary gland or adrenal disorders in medical history
8. Other malignant tumors within the last 5 years
9. Other concomitant diseases in medical history which according to Investigator may aggravate during the study, including uncontrolled diabetes mellitus, rectal diseases, rectal fissures, hemorrhoid, rectal polyps, rectostenosis, inflammatory urinary diseases: chronic prostatitis, cystitis, urethral catheter, chronic urine retention.
10. Complicated allergic history, systemic allergic reaction, any dietary allergy, intolerability, limitations or specific diets which according to the Investigator may be a contraindication for subject participation in the present study.
11. Administration of drug products which have a marked effect on immune system within 3 previous months prior the screening, long-term intake of disaggregants (warfarin, low molecular heparin except for ThromboASS).
12. Participation in other clinical studies or administration of investigational drug products within 30 days prior the screening, or persisting adverse reactions of any investigational drug product.
13. Any clinically significant patient's health disorders and/or laboratory abnormalities not enlisted in the Protocol which are identified at the screening, and/or any reason which according to the Investigator may prevent the patient's participation in the study.
14. Drug or alcohol abuse at the screening or in the past which according to the Investigator makes the patient ineligible for participation in the study: intake of more than 5 units of alcohol a week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of vine or 50 ml of alcohol) or anamnestic data on alcoholism, narcomania, drug abuse and/or history of significant alcohol or drug abuse inducing drug dependence, within one year prior the screening visit.
15. Vaccination made 14 days prior the study
16. Smoking of more than 10 cigarettes a day
17. Unability to understand or follow study instructions
18. Lack of availability during 29 days after administration of the investigational drug product, fails to follow visit schedule
19. Individual intolerability of the investigational drug product components
Study withdrawal criteria:
1. Any patient may refuse from the study participation on his own wish in any moment on any study stage.
2. Principal Investigator may withdraw any patient from the study in the following cases:
* Investigator makes the decision that a patient should be withdrawn in his own best interests
* Patient develops any serious adverse reactions/events in the screening period
* Patient has been enrolled to the study with violations, or does not follow the protocol requirements
* Patient needs additional treatment in the screening period
3. Sponsor has right to terminate the study in any moment.
4. Regulatory authorities have right to terminate the study in any moment.
45 Years
75 Years
MALE
No
Sponsors
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Panacela Labs LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Vsevolod B. Matveev, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences
Boris Y. Alexeev, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
Vladimir M. Moiseenko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
Sergey V. Mishugin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
Alexander K. Nosov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
Dmitry Y. Pushkar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Moscow State University of Medicine and Dentistry
Locations
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Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Sciences
Moscow, , Russia
Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
Moscow, , Russia
Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
Moscow, , Russia
Moscow State University of Medicine and Dentistry
Moscow, , Russia
Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
Saint Petersburg, , Russia
Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
Saint Petersburg, , Russia
Countries
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Other Identifiers
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PNC-M-VM3-01
Identifier Type: -
Identifier Source: org_study_id