Dose Escalation Study of MLN4924 in Adults With Melanoma
15. juli 2013 opdateret af: Millennium Pharmaceuticals, Inc.
A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma
This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
37
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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Santa Monica, California, Forenede Stater, 90404
- The Angeles Clinic and Research Institute
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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 all of the following criteria to be enrolled in the study:
- Diagnosis of metastatic melanoma
- Measurable disease
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
- Willing and able to give written informed consent
- Suitable venous access for study-required blood sampling
- Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug
- Systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment
- CYP3A inducers within 14 days of study treatment. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study
- No prior history of amiodarone in the 6 months before the first dose of MLN4924
- Diarrhea that is greater than Grade 1 as outlined in the protocol
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- Other clinical and laboratory assessments that do not meet the criteria specified in the protocol
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MLN4924
MLN4924 via IV infusion
|
Patients will be administered MLN4924 via an IV infusion.
Each 21-day treatment cycle is composed of 2 weeks intermittent dosing of MLN4924 on Days 1, 4, 8 and 11, followed by a rest period of 10 days.
A cohort of patients will receive a reduced first dose on Day 1, approximately half the strength of the dose received on Days 4, 8, 11 and dose will not be administered on Day 4 if the Day 1 dose is not tolerated.(Schedule
A ramp-up), or continuous weekly dosing (Days 1, 8, and 15) of MLN4924 (Schedule B)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924
Tidsramme: Up to 12 months of treatment
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Up to 12 months of treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Anti-tumor activities of MLN4924
Tidsramme: Up to 12 months of treatment
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Up to 12 months of treatment
|
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Pharmacodynamic effects of MLN4924 on blood and tumor cells
Tidsramme: Primarily assessed during the first cycle of therapy
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Primarily assessed during the first cycle of therapy
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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.
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. december 2009
Primær færdiggørelse (Faktiske)
1. maj 2012
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
9. november 2009
Først indsendt, der opfyldte QC-kriterier
10. november 2009
Først opslået (Skøn)
11. november 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. juli 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juli 2013
Sidst verificeret
1. juli 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C15005
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 .