- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00064584
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)
23. marts 2009 opdateret af: Millennium Pharmaceuticals, Inc.
Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia
This is the first study of the drug CT53518 when given to humans.
The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug.
The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body.
Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 1, open label, dose escalating study at five clinical sites to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome.
This study will confirm the tolerability and assess the effects on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication (ITD).
Undersøgelsestype
Interventionel
Tilmelding
60
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana Farber Cancer Institute
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New York
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New York, New York, Forenede Stater, 10021
- Memorial Sloan Kettering Cancer Center
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Medical Center
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Oregon
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Portland, Oregon, Forenede Stater, 97201
- Oregon Health Sciences University
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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:
Each patient must meet the following inclusion criteria to be eligible to participate in the study.
Men and women who are over 18 years of age and have one of the following conditions:
- AML with relapse within 12 months of the completion of consolidation therapy who are not to receive gemtuzumab-ozogamicin; or
- AML with relapse after 12 months of the completion of consolidation therapy for whom, in the opinion of the investigator, the risk of alternative therapy outweighs the possible benefit; or
- newly diagnosed AML refractory to conventional remission-induction chemotherapy ("refractory" is defined as >10% blasts in blood and/or bone marrow upon recovery from two cycles of standard cytarabine-based induction chemotherapy); or
- newly diagnosed, or previously treated AML, greater than 60 years of age and not or no longer a candidate for conventional remission-induction chemotherapy or gemtuzumab-ozogamicin
- No reproductive potential (surgically, post- menopausal, or using two methods of contraception)
- Demonstrated FLT-3 gene, internal tandem duplication mutation
- ECOG performance status of 0 to 2
- Has not received cytoreductive drug therapy for at least 4 weeks, and has not received hydroxyurea within 24 hours prior to first dose of the study drug
- Has not received a bone marrow transplant or peripheral blood stem cell transplant within the last two months
- Able to read and give written informed consent and has signed a consent form approved by the Investigator's Institutional Review Board (IRB)
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible to participate in the study:
- Participated in an investigational drug study in the last 30 days
- Serum Creatinine >2 mg/dL
- Evidence of a clinically significant liver disease by history, physical examination and/or laboratory data (e.g. transaminases exceeding 3 x ULN and/or total bilirubin > 2 mg/dL
- Known to have used illicit drugs within the last 30 days
- Has an uncontrolled active infection
- Pregnant or nursing mother
- Candidate for conventional chemotherapy (except hydroxyurea), including growth factors or hormonal therapy for cancer
- Any concomitant disease or condition which could interfere with or for which the treatment might interfere with the conduct of the study the, or which would, in the opinion of the Investigator and/or Sponsor, increase the risk of the patient's participation in the study. This includes but is not limited to alcoholism, drug dependency or abuse, psychiatric disease.
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. januar 2005
Studieafslutning (Faktiske)
1. juli 2005
Datoer for studieregistrering
Først indsendt
9. juli 2003
Først indsendt, der opfyldte QC-kriterier
9. juli 2003
Først opslået (Skøn)
10. juli 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. marts 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. marts 2009
Sidst verificeret
1. marts 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01-301
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 .
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