- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00113204
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma (IPi-504-01)
15. mai 2008 oppdatert av: Infinity Pharmaceuticals, Inc.
A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma
This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in patients with relapsed and/or relapsed, refractory multiple myeloma.
This study will examine how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body.
The study will also evaluate potential anti-tumor activity of IPI-504.
Studieoversikt
Detaljert beskrivelse
IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy.
Hsp90 is a protein chaperone that plays a central role in regulating protein homeostasis.
Hsp90 regulates the stability of key proteins (called "client proteins") and keeps them in the appropriate three dimensional shape so they can perform their cellular functions.
In addition, many of the proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival.
Thus Hsp90, a single molecular target that is a central integrator of multiple pathways important to cancer, is an ideal novel target for oncologic therapy.
Selective inhibition of Hsp90 will affect multiple downstream mechanisms to disrupt tumor growth and selectively kill cancer cells.
The anti-neoplastic effects of Hsp90 inhibition have been demonstrated both in vitro and in vivo for a variety of different hematologic and solid tumors including multiple myeloma.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21231
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center The David Jurist Research Center
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New York
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New York, New York, Forente stater, 10011
- St. Vincent's Comprehensive Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of relapsed or relapsed, refractory disease
- Age is greater or equal to 18 years at the time of signing the informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Ability to adhere to the study visit schedule and all protocol requirements
- Voluntarily sign an informed consent
- All baseline studies must be completed for determining eligibility within 21 days of study enrollment
- Women of child-bearing potential (WCBP) defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months must have a negative serum or urine pregnancy test prior to each cycle of treatment
- All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study
Exclusion Criteria:
- Disease specific treatment within the previous 3 weeks including use of chemotherapy that is known to be active or may be active against multiple myeloma
- Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor
- Participation in any investigational drug study within 3 weeks preceding start of treatment for conventional small molecule therapy or 4 weeks preceding the start of treatment for biologic or vaccine therapy; concurrent radiation therapy is not permitted
- Concomitant use of corticosteroids may not exceed prednisone 10 mg per day with the exception of pre-medication for transfusion of blood products and topical application
- Concurrent treatment with any agent that alters CYP3A activity (unless maintained on stable dose)
- Baseline QTc >450
- NYHA class 3 or 4 congestive heart failure
- Left Bundle Branch Block
- Mycardial infarction or active ischemic heart disease within 6 months
- Grade 3 or greater peripheral neuropathy
- Renal insufficiency, serum creatinine >2x upper limit of normal (ULN)
- Platelets < 30,000 mm3 or refractory to transfusion and unable to be maintained > 50,000 mm3
- AST and / or ALT > 2.0x ULN
- ANC <1,000 cells/mm3
- Hemoglobin < 8.0 g/dL
- Presence of active infection or systemic use of antibiotics within 72 hours of treatment
- WCBP who are breast feeding
- Significant co-morbid condition or disease which in the judgment of the investigator would place the patient at undue risk or interfere with the study (e.g. cardiac disease such as acute coronary syndrome or unstable angina within 6 months, New York Heart Association (NYHA) class 2 or greater congestive heart failure (CHF), uncontrolled hypertension, arrhythmia requiring medication or mechanical control, chronic obstructive pulmonary disease (COPD), cirrhotic liver disease, or other conditions)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine the safety and maximum tolerated dose of IPI-504
Tidsramme: Following 1 cycle of treatment
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Following 1 cycle of treatment
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Recommend a dose for subsequent studies of IPI-504
Tidsramme: Once MTD is reached
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Once MTD is reached
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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To examine the pharmacokinetic parameters of IPI-504
Tidsramme: During first dose first cycle of IPI-504
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During first dose first cycle of IPI-504
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To evaluate the potential anti-tumor activity with standard markers of disease progression
Tidsramme: 1 cycle of treatment
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1 cycle of treatment
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To examine pharmacodynamic markers of biologic activity of IPI-504
Tidsramme: Cycle 1 of treatment
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Cycle 1 of treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sundar Jagannath, MD, St. Vincent's Comprehensive Cancer Center
- Hovedetterforsker: David S. Siegel, MD; Ph.D, Hackensack Meridian Health
- Hovedetterforsker: Ivan Borrello, MD, Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. doi: 10.1517/14712598.2.1.3.
- Pratt WB, Toft DO. Regulation of signaling protein function and trafficking by the hsp90/hsp70-based chaperone machinery. Exp Biol Med (Maywood). 2003 Feb;228(2):111-33. doi: 10.1177/153537020322800201.
- Neckers L. Hsp90 inhibitors as novel cancer chemotherapeutic agents. Trends Mol Med. 2002;8(4 Suppl):S55-61. doi: 10.1016/s1471-4914(02)02316-x.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2005
Primær fullføring (Faktiske)
1. mars 2007
Studiet fullført (Faktiske)
1. mars 2007
Datoer for studieregistrering
Først innsendt
6. juni 2005
Først innsendt som oppfylte QC-kriteriene
6. juni 2005
Først lagt ut (Anslag)
7. juni 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. mai 2008
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mai 2008
Sist bekreftet
1. mai 2008
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
Andre studie-ID-numre
- IPI-504-01
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 Multippelt myelom
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
-
National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
-
National Cancer Institute (NCI)AvsluttetMyelom, multippel | Myelom-multippelForente stater
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Tel-Aviv Sourasky Medical CenterFullførtPlasmacellemyelom | Myelom-multippel | Myelom multippel | Myelom, plasmacelleIsrael
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National Cancer Institute (NCI)Georgetown University; Hackensack Meridian HealthAvsluttetMyelom-multippel | Myelom, plasmacelle | MyelomatoseForente stater
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University of ChicagoNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater, Canada
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Sidney Kimmel Cancer Center at Thomas Jefferson...FullførtStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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University of Southern CaliforniaNational Cancer Institute (NCI); Celgene CorporationAvsluttetStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TilbaketrukketStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelom
Kliniske studier på IPI-504
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Massachusetts General HospitalDana-Farber Cancer Institute; Infinity Pharmaceuticals, Inc.AvsluttetLungekreft | Stadium IV lungekreft | Stadium IIIb lungekreftForente stater
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Infinity Pharmaceuticals, Inc.FullførtGastrointestinale stromale svulster | MykvevssarkomerForente stater, Canada
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Infinity Pharmaceuticals, Inc.TilbaketrukketDedifferensiert liposarkomForente stater
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Infinity Pharmaceuticals, Inc.AvsluttetMetastatisk melanomForente stater
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Infinity Pharmaceuticals, Inc.Fullført
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Infinity Pharmaceuticals, Inc.FullførtProstatiske neoplasmer | Prostatakreft | Kreft i prostataForente stater
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Infinity Pharmaceuticals, Inc.FullførtIkke småcellet lungekreftForente stater, Ungarn, Taiwan, Korea, Republikken, Den russiske føderasjonen, Romania
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Bausch Health Americas, Inc.FullførtOnykomykoseForente stater, Den dominikanske republikk
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Infinity Pharmaceuticals, Inc.AstraZeneca; MedImmune LLCAvsluttetGastrointestinale stromale svulster
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Infinity Pharmaceuticals, Inc.AvsluttetBrystkreft | Metastatisk brystkreft | HER2 positiv brystkreft | BrystkreftForente stater, Spania