- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00171587
Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
18. november 2009 opdateret af: Novartis
A Phase IB, Open-label, Dose-escalating Study of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
The objective of this study is to assess the safety, tolerability, dose limiting toxicity, and maximum tolerated dose of vatalanib administered orally once daily in combination with capecitabine in patients with advanced cancer.
The study is also designed to determine the effect of vatalanib on the pharmacokinetics of capecitabine and the effect of capecitabine on the pharmacokinetics of vatalanib, and to describe the anti-tumor activity of this combination regimen.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
22
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with histologically confirmed advanced cancer that is refractory to standard therapy or for which no standard therapy exists (for dose escalation phase of the study only)
- Patients with histologically confirmed metastatic solid tumors or colorectal cancer presenting with metastatic disease and who received up to four prior chemotherapies for metastatic disease (for dose expansion phase of the study only)
- Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Age >= 18 years old
- Karnofsky Performance Status (KPS) of >= 70
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Hemoglobin (Hgb) >= 9 g/dl
- Platelets >= 100 x 10^9/L
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <= 3.0 x upper limit of normal (ULN)
- Serum bilirubin <= 1.5 x ULN
- Serum creatinine <= 1.5 x ULN and 24-hour creatinine clearance >= 50 ml/min
- Total urinary protein in a 24-hour urine collection <= 500 mg
- Life expectancy of greater than 3 months
- Written informed consent obtained according to local guidelines
Exclusion Criteria:
- Patients who have acute or chronic leukemias, lymphoma, or multiple myeloma
- Patients who have known bone marrow involvement with tumor
- Patients with a history of primary central nervous system tumors or brain metastases
- Prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant
- Patients who have had more than two prior chemotherapy regimens for metastatic disease (for dose escalation phase of the study only)
- Patients who have received chemotherapy less than 4 weeks (6 weeks for nitrosoureas or mitomycin-C and 2 weeks for vincristine) prior to entry on this study or who have not recovered from side effects of such therapy
- Patients who have received immunotherapy within 2 weeks or who have not recovered from side effects of such therapy
- Patients who have received radiotherapy within 2 weeks or who have not recovered from side effects of such therapy. The site of radiotherapy should not be the only site of measurable disease.
- Major surgery within 2 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy
- Patients who have received investigational drugs within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Oral, implantable, or injectable contraceptives are not considered an effective method of birth control for this study. (Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of chemotherapy).
- Concurrent severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
- Acute or chronic liver disease (e.g., hepatitis, cirrhosis)
- Confirmed diagnosis of HIV infection
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
- Patients who are taking Coumadin (warfarin sodium)
- Patients unwilling to or unable to comply with the protocol
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Sikkerhed
|
Tolerabilitet
|
Sekundære resultatmål
Resultatmål |
---|
Farmakokinetik
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2002
Primær færdiggørelse (Faktiske)
1. marts 2007
Studieafslutning (Faktiske)
1. marts 2007
Datoer for studieregistrering
Først indsendt
12. september 2005
Først indsendt, der opfyldte QC-kriterier
12. september 2005
Først opslået (Skøn)
15. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. november 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. november 2009
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CPTK787 0134/306220
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Neoplasma Metastase
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med PTK787/ZK 222584 (vatalanib)
-
David Rizzieri, MDNovartis PharmaceuticalsAfsluttetLymfom, storcellet, diffusForenede Stater
-
Northwestern UniversityNovartisAfsluttetSarkom | Tumorer i hjernen og centralnervesystemetForenede Stater
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)AfsluttetMalignt mesotheliomForenede Stater
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)AfsluttetMyelodysplastiske syndromer | Leukæmi | Myelodysplastiske/myeloproliferative neoplasmerForenede Stater
-
Novartis PharmaceuticalsAfsluttetVon Hippel-Lindau sygdom | Nethindehæmangioblastom | CNS hæmangioblastomForenede Stater
-
BayerAfsluttetIkke småcellet lungekræftFrankrig, Tyskland
-
NovartisBayerAfsluttetKolorektale neoplasmer | Rektale neoplasmer | Colon neoplasmerBelgien, Tyskland, Italien, Forenede Stater, Taiwan, Schweiz, Spanien, Canada, Slovakiet, Det Forenede Kongerige, New Zealand, Australien, Portugal, Brasilien, Ungarn, Tjekkiet, Frankrig, Holland, Sverige
-
George Albert FisherNovartisAfsluttetKræft i bugspytkirtlenForenede Stater
-
Washington University School of MedicineAfsluttetMyelomatoseForenede Stater
-
Novartis PharmaceuticalsBayerAfsluttetKolorektale neoplasmer | Rektale neoplasmer | Colon neoplasmerForenede Stater, Tyskland, Belgien, Canada, Spanien, Det Forenede Kongerige, Taiwan, Frankrig, Schweiz, Sverige, Portugal, New Zealand, Italien, Slovakiet, Australien, Østrig, Brasilien, Hong Kong