- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01497964
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy (GASTANA)
A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens
Primary Objective:
- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens
Secondary Objectives:
- To determine the RD of cabazitaxel when administered as a single agent every 3 weeks
- To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks
- To estimate the overall survival (OS) and progression free survival (PFS)
- To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 138-736
- Investigational Site Number 410001
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included)
- Signed informed consent
Exclusion criteria:
- Patients who have received >2 prior systemic chemotherapy regimens for advanced gastric cancer.
- For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria
- Eastern Cooperative Oncology Group performance status >1
- Age <18 years
- Inadequate organ and bone marrow function
- Prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
- Prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control)
- Previous treatment with cabazitaxel
- Known brain or leptomeningeal involvement of cancer
- Patients with known acquired immunodeficiency syndrome (AIDS) related illness or known HIV infection requiring antiretroviral treatment.
- Patients with active varicella zoster infection, or known hepatitis B or C infection.
- History of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cabazitaxel
Cabazitaxel, several dosages
|
Pharmaceutical form: solution for infusion Route of administration: intravenous
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objektiv responsrate
Tidsramme: Inntil 2 år
|
Inntil 2 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival (OS)
Tidsramme: Up to a maximum of 2 years
|
Up to a maximum of 2 years
|
Progression free survival (PFS)
Tidsramme: Up to a maximum of 2 years
|
Up to a maximum of 2 years
|
Number of patients with adverse events
Tidsramme: Up to a maximum of 2 years
|
Up to a maximum of 2 years
|
Pharmacokinetic parameter: Cmax
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
Pharmacokinetic parameter tmax
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
Pharmacokinetic parameter t1/2z
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
|
Pharmacokinetic parameter AUC
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
Pharmacokinetic parameter AUClast
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
Pharmacokinetic parameter CL
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
Pharmacokinetic parameter Vss
Tidsramme: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ARD12417
- U1111-1121-6247 (Annen identifikator: UTN)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Magekreft
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)FullførtRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertical Sleeve Gastrectomy | Magebånd | Bypass, GastricForente stater
-
Medtronic - MITGFullført
-
North Dakota State UniversityNational Institutes of Health (NIH)FullførtRoux en Y Gastric Bypass kirurgiForente stater
-
DuomedAktiv, ikke rekrutterendeOvervekt | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgia
-
Olympus Corporation of the AmericasUnity Health TorontoFullført
-
Wageningen UniversityRijnstate HospitalUkjentRoux-en-Y Gastric BypassNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtRoux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtRoux-en-Y Gastric Bypass | Magetømming | Bariatrisk kirurgiNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtSleeve Gastrectomy | Roux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtBariatrisk kirurgi | Jern absorpsjon | Roux- en -y Gastric BypassNederland
Kliniske studier på cabazitaxel XRP6258
-
SanofiFullførtOndartet solid svulst - ondartet nervesystemsneoplasmaForente stater, Canada
-
AIO-Studien-gGmbHSanofi; ClinAssess GmbHAvsluttetBrystkreft | Lungekreft | Tilbakevendende hjernemetastaser | Progressive hjernemetastaserTyskland
-
University of Alabama at BirminghamSanofiFullførtIkke-småcellet lungekreft (NSCLC) | Metastatisk NSCLC | Stage IV NSCLCForente stater
-
Dr Anjali ZarkarSanofiFullførtOvergangscellekarsinomStorbritannia
-
Hellenic Cooperative Oncology GroupSanofiFullført
-
SanofiFullførtAvansert solid svulstFrankrike, Spania
-
SanofiFullførtNeoplasmer, ondartetForente stater, Belgia, Danmark, Nederland, Sverige
-
SanofiFullførtNeoplasma ondartetForente stater
-
SCRI Development Innovations, LLCSanofi; GlaxoSmithKline; NovartisAvsluttetMetastatic Breast Cancer With Intracranial MetastasesForente stater
-
Case Comprehensive Cancer CenterTilbaketrukketKastratresistent metastatisk prostatakreft