- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00125411
Study of Satraplatin (JM-216) in Combination With Docetaxel
Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
- Life expectancy of at least 3 months
- Measurable or evaluable disease
- ECOG performance status of <= 2
- Willingness and ability to give informed consent
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Other chemotherapy treatment less than 4 weeks prior to enrollment
- Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum Tolerated Dose and Safety
Tidsramme: 3 weeks
|
3 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective response rate
Tidsramme: 3 weeks
|
3 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: George Wilding, MD, University of Wisconsin, Madison
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CO 04904
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 Tumorer
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Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRekruttering
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.RekrutteringNeoplasmer | Solid tumor | Ondartet tumorKina
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyRekrutteringSolid tumor, voksen | Refraktær tumorForenede Stater
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Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Taiwan, Forenede Stater, Australien
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Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtAvanceret solid tumor eller hæmatologisk tumorKina
Kliniske forsøg med satraplatin and docetaxel
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Shanghai Jiao Tong University School of MedicineFudan University; Qilu Hospital of Shandong UniversityRekruttering
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AgennixAfsluttet
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Southern Europe New Drug OrganizationPierre Fabre Laboratories; AgennixUkendt
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AgennixAfsluttet
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AgennixAfsluttetMaligniteterForenede Stater
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AgennixAfsluttetLungekræft | Karcinom, ikke-småcellet lungeForenede Stater
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AgennixAfsluttetProstatakræft | TumorerForenede Stater
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AgennixAfsluttetProstatakræftForenede Stater
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National Cancer Institute (NCI)AfsluttetFaste tumorer | Hjernetumorer | HjernemetastaserForenede Stater
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Afsluttet