- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01527929
Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment
An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
Primary Objective:
- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel
Secondary Objective:
- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
Panoramica dello studio
Descrizione dettagliata
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Bruxelles, Belgio, 1200
- Investigational Site Number 056002
-
Gent, Belgio, 9000
- Investigational Site Number 056001
-
-
-
-
-
Milano, Italia, 20133
- Investigational Site Number 380001
-
-
-
-
-
Rotterdam, Olanda, 3075 EA
- Investigational Site Number 528001
-
Utrecht, Olanda, 3584 CX
- Investigational Site Number 528002
-
-
-
-
-
Cambridge, Regno Unito, CB2 2QQ
- Investigational Site Number 826001
-
-
-
-
-
Barcelona, Spagna, 08035
- Investigational Site Number 724001
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria :
- Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.
- Eastern Cooperative Oncology Group performance status 0 - 2
- Stable renal function
Patients must have adequate liver and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5x10^9/L
- Platelets ≥ 100x10^9/L
- Total bilirubin ≤ 1.0 x the institutions upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal
- Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal
- Patient may have a Grade 1 or less neurotoxicity at study entry.
- Life expectancy > 3 months
- Age ≥ 18 years old
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
- Having given written informed consent prior to any procedure related to the study
Exclusion criteria:
- Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- Active hepatitis
- Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
- Patients requiring dialysis during the study.
- History of hypersensitivity to docetaxel or polysorbate 80.
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- Known brain metastases.
- If female, pregnancy or breast-feeding.
- Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
|
Pharmaceutical form: solution for infusion Route of administration: intravenous
|
Sperimentale: Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
|
Pharmaceutical form: solution for infusion Route of administration: intravenous
|
Sperimentale: Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
|
Pharmaceutical form: solution for infusion Route of administration: intravenous
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Pharmacokinetic profile of cabazitaxel in study population
Lasso di tempo: Up to day 10
|
Up to day 10
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
Lasso di tempo: up to 30 days after the last dosing
|
up to 30 days after the last dosing
|
Collaboratori e investigatori
Sponsor
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 (Stima)
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
- POP12251
- 2011-001517-14 (Numero EudraCT)
- U1111-1121-4512 (Altro identificatore: UTN)
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 .
Prove cliniche su Cabazitaxel XRP6258
-
SanofiCompletatoTumore solido maligno - Neoplasia maligna del sistema nervosoStati Uniti, Canada
-
AIO-Studien-gGmbHSanofi; ClinAssess GmbHTerminatoCancro al seno | Cancro ai polmoni | Metastasi cerebrali ricorrenti | Metastasi cerebrali progressiveGermania
-
University of Alabama at BirminghamSanofiCompletatoCarcinoma polmonare non a piccole cellule (NSCLC) | NSCLC metastatico | NSCLC stadio IVStati Uniti
-
Dr Anjali ZarkarSanofiCompletatoCarcinoma a cellule di transizioneRegno Unito
-
Hellenic Cooperative Oncology GroupSanofiCompletato
-
SanofiCompletatoTumore solido avanzatoFrancia, Spagna
-
SanofiCompletatoNeoplasie, maligneStati Uniti, Belgio, Danimarca, Olanda, Svezia
-
SanofiCompletatoNeoplasia malignaStati Uniti
-
Case Comprehensive Cancer CenterRitiratoCarcinoma prostatico metastatico resistente alla castrazione
-
The Clatterbridge Cancer Centre NHS Foundation...University of LiverpoolNon ancora reclutamento