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- Sperimentazione clinica NCT04113005
Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Following Desmopressin/Docetaxel treatment subjects will be subjected to routine medical oncology follow-up, including clinical appointments, laboratory and imaging workup as well as additional Docetaxel therapy every 21 days as indicated.
An additional study clinical appointment with blood work will be organized two days post Desmopressin/Docetaxel treatment. Furthermore, for detailed documentation of AEs during the first 21 days following Desmopressin/Docetaxel therapy, subjects will be assessed weekly via phone, and in person by the investigator/treating medical oncologist before the second dose of docetaxel.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Prima fase 1
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- Men over 18 years of age with histologically confirmed adenocarcinoma of the prostate.
- Signed Informed Consent Form indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- Castration-resistant stage of disease about to be treated with Docetaxel.
Baseline laboratory values as stated below:
- Absolute neutrophil count ≥1.5 x 109/L;
- Platelet count ≥125 x 109/L;
- Creatinine ≤1.5 x upper limit of normal;
- Urea ≤1.5 x upper limit of normal;
- Bilirubin ≤1.1 x upper limit of normal (unless elevated secondary to conditions such as Gilbert's disease);
- Aspartate transaminase (AST) ≤1.5 x upper limit of normal;
- Alanine transaminase (ALT) ≤1.5 x upper limit of normal;
- Castrate serum testosterone level (< 1.7 nmol/L).
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known Desmopressin intolerability.
- Any state of known congestive heart disease (CHF class >1).
- Sodium blood levels < 135 mEq/ml at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status >1.
- Moderate or severe chronic kidney disease (eGFR <60 mL/min).
- Prior use of docetaxel for CRPC.
≤30 days prior to study treatment received or had:
- Transfusion (platelets or red blood cells), or hematopoetic growth factors;
- Any type of chemotherapy;
- Any form of hormonal treatment with the exception of the continuous GnRH analogues required to maintain castrate state;
- Corticosteroid treatment equivalent to >10 mg of Prednisone orally daily;
- An investigational agent for prostate cancer;
- Ongoing Desmopressin therapy at enrollment;
- Major surgery.
- Current use of: Clofibrate, Chlorpropamide, Carbamazepine, Demeclocycline, Lithium, or Norepinephrine.
- History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated (brain imaging for asymptomatic subjects is not required).
- Current symptomatic cord compression requiring surgery or radiation therapy (once successfully treated and there has been no progression, subjects are eligible for the study).
- Uncontrolled medical conditions such as diabetes mellitus, angina pectoris, serious cardiac arrhythmia, severe hypertension, or active infection requiring systemic antibiotics, or any event such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to protocol therapy, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Desmopressin
Aim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment.
|
To evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment.
Additionally, CTCs will be collected before and after Desmopressin/Docetaxel treatment to evaluate therapeutic efficacy.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of subjects presenting with AEs within a 21-day period of time post Desmopressin/Docetaxel treatment; nature and severity of AEs (as per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, Appendix B).
Lasso di tempo: 12 months
|
Number of subjects presenting with AEs within a 21-day period of time post Desmopressin/Docetaxel treatment; nature and severity of AEs (as per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, Appendix B). The proportion of subjects presenting with hyponatremia at 48-hour time point; severity of hyponatremia as per CTCAE Version 4.03 (Appendix B). |
12 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Urban Emmenegger, Sunnybrook Research Institute
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Desmopressin Trial
Piano per i dati dei singoli partecipanti (IPD)
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