- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02105350
A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer
A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.
MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary cancer.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
- Have measurable disease.
- Not received prior systemic therapy for advanced biliary cancer.
- Age 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Estimated life expectancy is greater than 3 months.
- Have adequate hematological function.
- Have adequate cardiac function.
- All radiology studies performed within 4 weeks prior to the start of therapy.
- No evidence of active uncontrolled infection.
- Ability to understand and willing to sign a written informed consent document.
- Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration.
- Able to take oral medications.
Exclusion Criteria:
- Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
- Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
- Histopathological or cytological diagnosis of ampullary carcinoma.
- Incomplete recovery from previous surgery.
- Undergoing current treatment with curative intent.
- History of prior malignancy that could interfere with the response evaluation.
- Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial.
- Any psychiatric or other disorder likely to impact on informed consent.
- Pregnant or nursing (lactating) women.
- Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
- Significant cardiac disease.
- History of retinal degenerative disease.
- History of Gilbert's syndrome.
- Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection.
- Neuromuscular disorders that are associated with elevated creatine kinase.
- Planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
- Impairment of gastrointestinal function or gastrointestinal disease.
- Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
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: MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day.
Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
|
Andre navn:
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total incidence of grade 3 and 4 adverse events
Tidsramme: 2 years
|
2 years
|
Total rate of grade 3 and 4 adverse events
Tidsramme: 2 years
|
2 years
|
Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of patients with objective response rate
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jennifer Knox, M.D., Princess Margaret Cancer Centre
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
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Karsinom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
- Oksaliplatin
Andre studie-ID-numre
- Biliary GEMOX / MEK
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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