- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00148902
Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)
4 dicembre 2017 aggiornato da: GlaxoSmithKline
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)
This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
52
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Michigan
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Detroit, Michigan, Stati Uniti, 48201
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- GSK Investigational Site
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Advanced solid tumors.
- Able to swallow oral medication.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: All treated subjects
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
|
docetaxel
lapatinib
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of subjects with adverse events (AEs) or serious AEs (SAEs)
Lasso di tempo: Up to 7 weeks in each cycle
|
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention will be categorized as SAE.
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Up to 7 weeks in each cycle
|
Number of subjects with abnormal change from Baseline in laboratory parameters
Lasso di tempo: Baseline and up to 7 weeks in each cycle
|
Blood sample will be collected to evaluate laboratory parameters.
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Baseline and up to 7 weeks in each cycle
|
Number of subjects with Optimally Tolerated regimen
Lasso di tempo: Up to 7 weeks in each cycle
|
Optimally Tolerated regimen is a dose regimen where 1 out of 6 subjects experiences a dose-limiting toxicity (DLT).
|
Up to 7 weeks in each cycle
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1)
Lasso di tempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2)
Lasso di tempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Cmax of GW572016 alone (PK cohort 2)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Cmax of GW572016 when given in combination with docetaxel (PK cohort 1)
Lasso di tempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
Cmax of GW572016 when given in combination with docetaxel (PK cohort 2)
Lasso di tempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Tmax of GW572016 alone (PK cohort 2)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Tmax of GW572016 when given in combination with docetaxel (PK cohort 1)
Lasso di tempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
|
Tmax of GW572016 when given in combination with docetaxel (PK cohort 2)
Lasso di tempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
|
Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
|
AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Clearance (CL) for docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Elimination half-life (Thalf) for docetaxel alone (PK cohort 1)
Lasso di tempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
|
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
|
Number of subjects with complete response
Lasso di tempo: Week 3 of every third cycle
|
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
|
Week 3 of every third cycle
|
Number of subjects with partial response
Lasso di tempo: Week 3 of every third cycle
|
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
|
Week 3 of every third cycle
|
Number of subjects with stable disease
Lasso di tempo: Week 3 of every third cycle
|
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
|
Week 3 of every third cycle
|
Number of subjects with progressive disease
Lasso di tempo: Week 3 of every third cycle
|
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
|
Week 3 of every third cycle
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
28 aprile 2003
Completamento primario (Effettivo)
21 gennaio 2006
Completamento dello studio (Effettivo)
21 gennaio 2006
Date di iscrizione allo studio
Primo inviato
6 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
6 settembre 2005
Primo Inserito (Stima)
8 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 dicembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 dicembre 2017
Ultimo verificato
1 dicembre 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Inibitori della chinasi proteica
- Docetaxel
- Lapatinib
Altri numeri di identificazione dello studio
- EGF10021
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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