- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01097512
AS703569 and Gemcitabine Combination in Advanced Malignancies
A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions:
Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment.
Male or female with at least 18 years of age. Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
No more than 3 prior chemotherapy regimens for advanced/metastatic disease.
At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged.
Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by:
Serum creatinine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Regimen 1: AS703569/gemcitabine
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle
|
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Andre navn:
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Andre navn:
|
Eksperimentell: Regimen 2: AS703569/gemcitabine
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle
|
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Andre navn:
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum tolerated dose (MTD)
Tidsramme: 21 days
|
To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.
|
21 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Treatment-emergent adverse events (TEAE)
Tidsramme: Minimum 21 days or 1 cycle
|
Proportion/number of subjects with TEAE's during the first and subsequent treatment cycles in each cohort for each of the 2 regimens.
|
Minimum 21 days or 1 cycle
|
Progression-Free Survival (PFS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Tidsramme: Variable
|
PFS time is defined as time (in months) from first drug intake to date of progression as reported and documented by the investigator (i.e.
radiological progression per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or death from any cause.
|
Variable
|
Time to Tumor Progression (TTP) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Tidsramme: Variable
|
TTP time is defined as the time (in months)from first drug intake to the date of progression, as reported and documented by the Investigator (i.e.
radiological progression per RECIST).
|
Variable
|
Overall Survival (OS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Tidsramme: Variable
|
OS time is defined as the time (in months) from first drug intake to any cause of death.
|
Variable
|
Progressive disease (PD)
Tidsramme: Every other cycle
|
Proportion of patients with progressive disease as assessed at the end of every other cycle according to disease-specific guidelines
|
Every other cycle
|
Best overall response (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Tidsramme: Every other cycle
|
For subjects with locally advanced /metastatic pancreatic cancer: Best overall response: presence of at least one confirmed Complete Response (CR) or confirmed Partial Response (PR) (using RECIST v1.0) during treatment in the 2 regimens as assessed at the end of every other cycle. |
Every other cycle
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Narmyn Rejeb, MD, Merck Serono S.A., Geneva
Publikasjoner og nyttige lenker
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
- 27902
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 Bukspyttkjertelkreft
-
Tianjin Medical University Cancer Institute and...Har ikke rekruttert ennåPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalia
-
Cedars-Sinai Medical CenterRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaForente stater
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalia
-
Radboud University Medical CenterDutch Cancer SocietyRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaNederland
-
Thomas Jefferson UniversityUkjentBukspyttkjertelfistel | Distal pankreatektomikomplikasjoner | Falciform Patch Pancreatic Closure | Fibrinlim bukspyttkjertellukkingForente stater
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... og andre samarbeidspartnereRekrutteringBukspyttkjertelkreft | PDAC - Pancreatic Ductal AdenocarcinomaStorbritannia
-
Chinese PLA General HospitalRekrutteringNeoplasmer i bukspyttkjertelen | Bukspyttkjertelkreft | Bukspyttkjertelkreft | PDAC - Pancreatic Ductal AdenocarcinomaKina
-
Andrei IagaruIkke lenger tilgjengeligKarsinoide svulster | Islet Cell (Pancreatic NET) | Andre nevroendokrine svulsterForente stater
Kliniske studier på AS703569/gemcitabine
-
EMD SeronoAvsluttetEn fase I, dose-eskaleringsstudie av AS703569 gitt oralt til personer med hematologiske maligniteterHematologiske maligniteterItalia, Forente stater, Sveits, Belgia, Tyskland
-
IBSA Farmaceutici Italia SrlUniversita degli Studi di Catania; Informapro SrlRekruttering
-
AstraZenecaRekrutteringGaldeveiskreftFrankrike, Spania, Italia, Korea, Republikken, Japan, Tyskland, Forente stater, Singapore
-
Sierra Oncology LLC - a GSK companyFullførtAvanserte solide svulsterSpania, Storbritannia
-
University of Erlangen-Nürnberg Medical SchoolFullførtBukspyttkjertelkreftTyskland
-
Shenzhen University General HospitalHar ikke rekruttert ennå
-
Kansai Hepatobiliary Oncology GroupFullført
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekruttering
-
3D Medicines (Sichuan) Co., Ltd.Har ikke rekruttert ennåNeoplasmer i galleveiene
-
Samsung Medical CenterFullførtBukspyttkjertelkreftKorea, Republikken