- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02654938
Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
Multicenter, Randomized, Single-blind Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Mobilan is a type V adenovirus carrying TLR5 receptor and its agonist, protein 502s. It's mechanism of action involves activation of immune system and extensive mobilisation of various immunocytes to administration locus. It's safety and tolerability is currently evaluated in first-in-man phase I study in prostate cancer patients. Treatment strategy for the disease (radical prostatectomy or active observation) will be determined by the Investigator in accordance with routine clinical practice of the hospital.
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Moscow, Federazione Russa
- Moscow State University of Medicine and Dentistry
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Moscow, Federazione Russa
- Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
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Moscow, Federazione Russa
- Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Sciences
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Moscow, Federazione Russa
- Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
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Saint Petersburg, Federazione Russa
- Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
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Saint Petersburg, Federazione Russa
- Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subscribed Informed consent for participation in the trial
- Men aged 45 to 75 years
- Patients with histologically verified prostate cancer, stage Т1-Т2, N0, M0
- Patient's ECOG status 0-2
- 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:
- Failure to obtain Informed consent
- Clinical or radiological signs of metastases
- Indication to hormone therapy of prostate cancer
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.)
- Clinically significant CNS diseases at the screening
- Current infection or another severe or systemic disease which increases risk of treatment sequelae
- Pituitary gland or adrenal disorders in medical history
- Other malignant tumors within the last 5 years
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Vaccination made 14 days prior the study
- Smoking of more than 10 cigarettes a day
- Unability to understand or follow study instructions
- Lack of availability during 29 days after administration of the investigational drug product, fails to follow visit schedule
- Individual intolerability of the investigational drug product components
Study withdrawal criteria:
- Any patient may refuse from the study participation on his own wish in any moment on any study stage.
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
- Sponsor has right to terminate the study in any moment.
- Regulatory authorities have right to terminate the study in any moment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Mobilan (M-VM3)
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product
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Mobilan (M-VM3), farmaco sperimentale innovativo basato su un sistema di rilascio adenovirale non replicato costituito da un vettore genomico che codifica il recettore TLR5 e il suo ligando 502.
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Comparatore placebo: Placebo
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)
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5% infusion solution of dextrose
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Frequency and intensity of adverse events (according to CTCAE v 4.03 classification)
Lasso di tempo: Baseline to up to 29 days after the drug administration
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Baseline to up to 29 days after the drug administration
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Exposure of Mobilan DNA vector in patient's peripheral blood
Lasso di tempo: Baseline to up to 29 days after the drug administration
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Using validated PCR assay
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Baseline to up to 29 days after the drug administration
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Prostate-specific antigen (PSA) measure
Lasso di tempo: On Day 29 after the drug administration
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Baseline PSA level will be taken from medical history
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On Day 29 after the drug administration
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Immune cell count in whole blood of patients assessed with flow cytometry
Lasso di tempo: Baseline to up to 29 days after the drug administration
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Including leucocytes, lymphocytes, T-lymphocyte, leukocyte index, total T-lymphocytes, CD3, T-helper cells CD3 + CD4 +, T-cytotoxic CD3 + CD8 +, regulation index (CD4 / CD8), double-cells CD4 + / CD8 +, NK cells CD3-CD (16 + 56) +, TNK-cells CD3 + CD (16 +56) +, B-lymphocytes CD19 +, 0-lymphocytes
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Baseline to up to 29 days after the drug administration
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Histopathological assessment of prostate tissue using Gleason grading system (if prostatectomy is made in the study period, and material is available for analysis)
Lasso di tempo: On Day 29 after the drug administration
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The Gleason grading system is used to evaluate the stage of prostate cancer using samples from biopsy or post-surgical samples as follow: 1 - The cancerous prostate closely resembles normal prostate tissue. 2 - The tissue still has well-formed glands, but they are larger and have more tissue between them. 3 - The tissue still has recognizable glands, but the cells are darker. 4 - The tissue has few recognizable glands. 5 - The tissue does not have any or only a few recognizable glands. |
On Day 29 after the drug administration
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Presence of protein 502s in blood plasma
Lasso di tempo: Baseline to up to 29 days after the drug administration
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Using ELISA assay
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Baseline to up to 29 days after the drug administration
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Titer of 502 antibodies (AB) in peripheral blood serum
Lasso di tempo: Baseline to up to 29 days after the drug administration
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Using ELISA assay
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Baseline to up to 29 days after the drug administration
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Histopathological assessment of prostate tissue using Irani scale (if prostatectomy is made in the study period, and material is available for analysis)
Lasso di tempo: On Day 29 after the drug administration
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Irani J (1997) scale include histological assessment of slide mounts obtained after operation as follow: Degree of immune cell infiltration: 0 - No inflammatory cells, 1 - Scattered inflammatory cell infiltrate within the stroma without lymphoid nodules, 2 - Nonconfluent lymphoid nodules, 3 - Large inflammatory areas with confluence of infiltrate |
On Day 29 after the drug administration
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Vsevolod B. Matveev, MD, PhD, Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences
- Investigatore principale: Boris Y. Alexeev, MD, PhD, Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
- Investigatore principale: Vladimir M. Moiseenko, MD, PhD, Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
- Investigatore principale: Sergey V. Mishugin, MD, PhD, Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
- Investigatore principale: Alexander K. Nosov, MD, PhD, Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
- Investigatore principale: Dmitry Y. Pushkar, MD, PhD, Moscow State University of Medicine and Dentistry
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PNC-M-VM3-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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