- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00003403
GPX-100 in Treating Patients With Solid Tumors
Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes in disease status in this patient population.
OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100 IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses with prior doxorubicin) in patients with responding or non-progressing disease. One patient is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Florida
-
Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic Jacksonville
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84132
- Huntsman Cancer Institute
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS: Incurable, solid tumors in patients who are not candidates for effective systemic therapy Progressive disease defined as a 25% increase in diameter of measurable lesions or appearance of new lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 16 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin within normal limits SGOT no greater than 1.5 times normal (2.5 times normal with disease involvement) Alkaline phosphatase no greater than 2.5 times normal PT or PTT less than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure, active ischemic heart disease, or uncontrolled hypertension No myocardial infarction within the past 6 months Other: Not pregnant or nursing (negative pregnancy test required) Fertile patients must use effective contraception No weight loss of 10% or more in the past 3 months No frequent vomiting No severe anorexia
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No greater than 300 mg/m2 cumulative dose of doxorubicin No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormone therapy No concurrent anticancer hormone therapy Concurrent corticosteroids allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational drug therapy No other concurrent investigational therapy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Frederick J. Dechow, PhD, Gem Pharmaceuticals
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CDR0000066409
- GEM-97-002
- MAYO-IRB-153-98
- NCI-V98-1441
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op GPX-100
-
Gem PharmaceuticalsBeëindigdBorstkanker | MetastaseVerenigde Staten, Bulgarije
-
Gem PharmaceuticalsVoltooidGevorderde solide tumoren - Fase 1-populatieVerenigde Staten
-
Gem PharmaceuticalsVoltooidWekedelensarcoomVerenigde Staten
-
University of FloridaIngetrokkenAortastenose | Vervanging van de transkatheter-aortaklep | Glutathionperoxidase-activiteitVerenigde Staten
-
University of California, Los AngelesIngetrokkenTandvleesaandoeningen | Tandpulpnecrose | Zenuwwortelpijn NecVerenigde Staten
-
OrthoTrophix, IncVoltooid
-
Wageningen UniversityFriesland CampinaOnbekendVoeding | Metabolisme | Genomica | Postprandiaal metabolismeNederland
-
San Diego State UniversityVoltooid
-
Sumitomo Pharma America, Inc.BehaVR LLCVoltooidSociale angststoornis (SAD)Verenigde Staten
-
ShireVoltooidAcute virale conjunctivitisVerenigde Staten, Brazilië