- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00925743
A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
Studieoversikt
Detaljert beskrivelse
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90048
- Investigational Site Number 840008
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San Diego, California, Forente stater, 92123
- Investigational Site Number 840003
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Illinois
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Decatur, Illinois, Forente stater, 62526
- Investigational Site Number 840010
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Investigational Site Number 840002
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Investigational Site Number 840006
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Ohio
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Cincinnati, Ohio, Forente stater, 45267-0542
- Investigational Site Number 840007
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Texas
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San Antonio, Texas, Forente stater, 78229
- Investigational Site Number 840005
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
Exclusion criteria
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
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: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
|
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Tidsramme: first cycle (i.e.3 weeks)
|
first cycle (i.e.3 weeks)
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Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
Tidsramme: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
|
Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
Tidsramme: up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to progression (TTP) (part 1 and 2)
Tidsramme: up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
Duration of response (DR) (Part 1 and 2)
Tidsramme: up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
Cabazitaxel pharmacokinetic (part 1 and 2)
Tidsramme: up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
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
Andre studie-ID-numre
- TCD10870
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. .
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