- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00752570
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
- One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
- At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated <= 28 days before randomization
- Radiographically documented disease progression per modified RECIST criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
- ECOG performance status of 0 or 1
- Man or woman >= 18 years of age
- Adequate end organ assessments by laboratory studies (hematological and chemistries)
- Life expectancy >= 3 months
Exclusion Criteria:
Exclude subjects with a history of prior malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Prior irinotecan therapy
- Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
- Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
- Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= CTC grade 2 [CTCAE version 3.0])
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 2
AMG 386 placebo QW, FOLFIRI Q2W
|
AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386. FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours. FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest. |
Aktiv komparator: 1
Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W
|
Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386. FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours. FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest.
AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo.
Tidsramme: The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).
|
The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate other measures of efficacy or clinical response including objective response rate (ORR), duration of response (DOR), overall survival (OS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo
Tidsramme: Treatment phase or until disease progression
|
Treatment phase or until disease progression
|
To evaluate progression free survival and measures of efficacy by KRAS status
Tidsramme: Treatment phase
|
Treatment phase
|
To evaluate patient reported outcomes (PROs), relative dose intensity, incidence of anti AMG 386 antibody formation, pharmacokinetics of AMG 386 (Cmax and AUC) and safety (incidence of AEs and significant laboratory changes)
Tidsramme: Throughout study
|
Throughout study
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
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
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Karsinom
- Kolorektale neoplasmer
- Gastrointestinale neoplasmer
- Kolon neoplasmer
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Trebananib
Andre studie-ID-numre
- 20070307
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 AMG 386 Placebo
-
AmgenFullførtKarsinom | Kreft | Eggstokkreft | Egglederkreft | Solide svulster | Onkologi | Tumorer | Metastaser | Gynekologiske maligniteterBelgia, Forente stater, Australia
-
AmgenFullførtAvansert nyrecellekarsinom
-
National Cancer Institute (NCI)FullførtTilbakevendende bløtvevssarkom hos voksne | Stage III Bløtvevssarkom for voksne | Stage IV Bløtvevssarkom for voksne | Angiosarkom hos voksneForente stater
-
AmgenFullførtEggstokkreft | Egglederkreft | Primær peritoneal kreft
-
AmgenFullførtKreft | Brystkreft | Brystneoplasmer | Metastatisk kreft | Brystsvulster | Solide svulster | Onkologi | Tumorer | Metastaser | Lokalt tilbakevendende og metastatisk brystkreftForente stater, Belgia, Frankrike
-
AmgenFullførtNedsatt nyrefunksjon | Avanserte solide svulster | NyresykdomForente stater
-
AmgenFullførtEggstokkreft | Egglederkreft | Primær peritoneal kreftForente stater, Frankrike, Italia, Spania, Storbritannia, Belgia, Canada, Polen, Sveits, Korea, Republikken, Den russiske føderasjonen, Hong Kong, Portugal, Sør-Afrika, Israel, Romania, Bulgaria, Hellas, Australia, Sverige, Japan, L... og mer
-
National Cancer Institute (NCI)FullførtNeoplasma i sentralnervesystemet | Solid neoplasmaForente stater, Canada
-
Chong Kun Dang PharmaceuticalUkjentHypertensjon | DyslipidemierKorea, Republikken