- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01574937
XL-184+Abiraterone in Post-Chemo CRPC
A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for use in participants, including people with your type of cancer.
In this research study, we are testing the safety of XL184 at different dose levels. XL184 is a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may prevent tumor growth by stopping the formation of blood vessels inside the tumor and also shrink tumors.
This drug has been used in early-stage studies and is also currently being studied in other trials. Information from those other research studies suggests that XL184 may help to slow or stop tumor growth including prostate cancer. We will also be taking blood and urine tests to look at how your body processes the drug.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The following procedures will be performed during this study. On Day 1 for every cycle (28 days/4 weeks)-The following will be undertaken prior to initiating study therapy and on day 1 of every subsequent cycle: A medical history, physical exam, performance status, blood tests, urine test.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
We will actively monitor your condition for up to 30 days after you come off the study. If you come off study for a side effect we will monitor your condition until the resolution or stabilization of the side effect
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- CRPC with up to 2 prior chemotherapy regimens
- Progressive disease on CT, MRI or bone scan per mRECIST
- Has recovered to baseline/CTCAE less than or equal to Grade 1 from toxicities related to prior treatment (except alopecia)
- Agree to use accepted barrier method of contraception
Exclusion Criteria:
- Cytotoxic chemotherapy within 3 weeks
- Prior treatment with cabozantinib or other c-MET inhibitor
- Prior therapy with a lyase inhibitor
- Concurrent use of hormonal therapies other than LHRH analogue or orchiectomy
- Received radiation therapy to thoracic cavity or GI tract within 3 months, to bone or brain metastasis within 2 weeks or to any other site within 4 weeks of first dose of study drug
- Prior treatment with a small molecular kinase inhibitor within 2 weeks of study entry
- Received another investigational product within 28 days prior to study entry
- Active brain metastases or epidural disease
- Requires concomitant treatment in therapeutic doses with warfarin or warfarin-related agents
- No uncontrolled significant intercurrent or recent illness
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: Treatment Arm
Cabozantinib and abiraterone
|
28 day cycle
Andre navn:
28 day cycle
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum Tolerated Dose
Tidsramme: 2 years
|
To define the MTD of cabozantinib in combination with abiraterone
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Definition of a Dosing Regimen
Tidsramme: 2 years
|
To define a dosing regimen of abiraterone and cabozantinib suitable for further evaluation based on long term toxicity and efficacy data
|
2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christopher Sweeney, MBBS, Dana-Farber Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-441
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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 Cabozantinib
-
University of BolognaIpsen; Bioikos Ambiente Srl; AOU S.Orsola Malpighi-Unit of Oncologic Molecular... og andre samarbeidspartnereUkjentIkke småcellet lungekreftItalia
-
ExelixisFullførtKreft | NSCLC | Solide svulsterJapan
-
Karsten GavenisRekrutteringNevroendokrine svulster | Nevroendokrint karsinomTyskland, Østerrike
-
Institut für Klinische Krebsforschung IKF GmbH...IpsenRekrutteringHepatocellulært karsinom Ikke-resektabelt | Metastatisk hepatocellulært karsinomTyskland
-
Istituto Oncologico Veneto IRCCSAktiv, ikke rekrutterende
-
Spanish Oncology Genito-Urinary GroupApices Soluciones S.L.FullførtHøy alder; Svakhet | Nyrekarsinom MetastatiskSpania
-
Stephen Chan LamAktiv, ikke rekrutterende
-
ExelixisGodkjent for markedsføringMedullær kreft i skjoldbruskkjertelenForente stater
-
Jennifer KingExelixisRekrutteringOvarial kimcellesvulst | Seminom | Kimcelletumor | Ikke-seminomatøs kimcelletumorForente stater
-
Memorial Sloan Kettering Cancer CenterExelixisRekruttering