- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00562224
Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients
26. september 2011 opdateret af: Pharmacyclics LLC.
Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients With Advanced Cancer
To determine the highest dose of study drug that can be taken without causing serious side effects in patients with advanced cancer.
The study will look at safety of the study drug and whether the treatment schedule is tolerated by patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
36
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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Greenbrae, California, Forenede Stater, 94904
- California Cancer Care
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Research Institue
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Texas
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Houston, Texas, Forenede Stater, 77030
- MD Anderson Cancer Center
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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:
- age ≥ 18 years
- Histologically confirmed, measurable solid tumor, non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, or multiple myeloma that has relapsed after standard therapy or for which no standard therapy exists
- Ability to swallow oral capsules without difficulty
- Estimated life expectancy > 12 weeks
- ECOG performance status ≤ 2
- Creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × institutional ULN (unless elevated from documented Gilbert's syndrome)
- AST and ALT ≤ 2.5 × institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases)
- Platelet count ≥ 100,000/µL
- ANC ≥ 1500/µL
- Hgb ≥ 9.0 g/dL
- Patients with previously treated, stable, asymptomatic brain metastases who are not on corticosteroids are eligible
- Willing and able to sign a written informed consent-
Exclusion Criteria:
- Patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to first day of drug dosing
- Patients who have undergone major surgery within 4 weeks prior to first day of drug dosing
- Patients who have received another investigational drug within 4 weeks
- Evidence of leptomeningeal metastasis
- Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (eg, WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy)
- Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
- Patients with risk factors for, or who are receiving medications known to prolong QTc interval and that may be associated with Torsades de Pointes
- QTc prolongation (defined as a QTc interval ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
- Patients with known HIV infection
- Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
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)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Arm 1
All study subjects will receive PCI-24781 (study drug).
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Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart ("TID"), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached.
If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart ("BID").
If a DLT occurs on the "BID" schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).
If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Dose limiting toxicity assessment at the end of the first 28 day cycle.
Tidsramme: at the end of the first 28 day cycle
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at the end of the first 28 day cycle
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Tumor response Measure: Pharmacokinetic/Pharmacodynamic assessments
Tidsramme: AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1
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AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. november 2007
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. september 2010
Datoer for studieregistrering
Først indsendt
19. november 2007
Først indsendt, der opfyldte QC-kriterier
19. november 2007
Først opslået (Skøn)
21. november 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. september 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. september 2011
Sidst verificeret
1. september 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Neoplasmer, Plasmacelle
- Leukæmi
- Leukæmi, B-celle
- Lymfom
- Myelomatose
- Hodgkins sygdom
- Lymfom, Non-Hodgkin
- Leukæmi, lymfatisk, kronisk, B-celle
- Leukæmi, lymfoid
- Neoplasmer efter sted
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Histon deacetylase hæmmere
- Abexinostat
Andre undersøgelses-id-numre
- PCYC-0402
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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