Kurzprotokoll - Kompetenznetz Leukämie

Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
AML MEK
Öffentlicher Titel
Trial of Mitogen-activated Protein/Extracellular Signal-regulated Kinase Kinase (MEK)
Inhibitor
Wissenschaftl. Titel
Phase II Trial With Safety-Run-In of MEK Inhibitor AS703026 In Subjects With Poor
Prognosis Acute Myeloid Leukemia and Other Hematological Malignancies
Kurztitel
AML MEK
Studiennummer KN/ELN
LN_NN_2009_380
Studiengruppe
NN
Studienart
randomisiert, offen
Studienphase
Phase II
Erkrankung
Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium
de novo/non-treated
Ziele
-
Phase 1: To determine the maximum tolerated dose (MTD) for each of the two
regiments of AS703026 in subjects with advanced hematological malignancies.
-
Phase 2: To assess the anti-leukemic activity of two regimens of AS703026 in older
subjects with newly diagnosed poor prognosis Acute Myeloid Leukemia (AML) who
are not candidates for intensive chemotherapy.
-
Phase 1: To provide preliminary findings on the safety profile of AS703026 in
subjects with hematological malignancies.
-
Phase 1: To assess the pharmacokinetics (PK) of AS703026 in subjects with
advanced hematological malignancies.
-
Phase 1: To assess the anti-leukemic activity of AS703026 in subjects with advanced
hematological malignancies.
-
Phase 2: To determine the safety and tolerability of AS703026 in older subjects with
newly diagnosed poor prognosis AML.
-
Phase 1:
-
Subjects with one of the following conditions:
-
Primary or secondary Acute Myeloid Leukemia, pathologically confirmed according to
World Health Organization classification
-
Subjects with myelodysplastic syndrome, International Prognostic Scoring System Int
-2 or high risk who are resistant or intolerant to standard treatment and not
candidates for transplantation,
-
Subjects with relapsed or refractory multiple myeloma, who have failed or are
intolerant to at least two prior therapies including thalidomide, lenalidomide and
bortezomib,
-
Subjects with advanced myeloproliferative disorders for whom no established
treatment options are available,
-
Subjects with acute lymphocytic leukemia, relapsed, refractory or intolerant to
standard treatment and for whom no effective treatment options are available,
-
Age greater than or equal to 18 years.
-
Subjects have read and understood the Informed Consent Form
-
Subjects and their partners must be willing to avoid pregnancy during the trial
-
Phase 2:
-
Subjects with newly diagnosed primary or secondary Acute Myeloid Leukemia
pathologically confirmed according to World Health Organization classification who
have NOT been exposed to any prior therapy for Acute Myeloid Leukemia.
-
Subjects meet at least one of the following conditions:
-
Age greater than or equal to 75 years OR
Einschlusskriterien
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
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Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
AML MEK
Ausschlusskriterien
-
Age greater than or equal to 60 and less than 75 years with at least one of the
following poor prognostic factors:
-
Secondary Acute Myeloid Leukemia
-
At least one of the following unfavorable cytogenetic abnormalities: del(5q), -5, -7,
del(7q), abn 3q, 9q, 11q, 20q, 21q, 17p, t(6;9), t(9;22) or complex karyotypes (greater
than or equal to 3 unrelated abnormalities)
-
Eastern Cooperative Oncology Group status 2
-
Subjects have read and understood the Informed Consent Form
-
Subjects and their partners must be willing to avoid pregnancy during the trial and
until 1 month after the last trial drug administration.
-
Phase 1 and Phase 2:
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Eastern Cooperative Oncology Group performance status 3 or greater,
-
Hyperleukocytosis with greater than 30x10 to the ninth power per L leukemia blasts in
peripheral blood,
-
Acute promyelocytic leukemia
-
Administration of any antineoplastic therapy within at least 2 weeks
-
Participation in other clinical trials within at least 2 weeks of the first AS703026 dose,
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Active central nervous system leukemia,
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Active and uncontrolled infection
-
Other significant disease
-
Major surgery within two weeks prior to trial entry,
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Liver function tests above specific limits
-
International normalized ratio greater than 1.5 x ULN unless on treatment with
warfarin,
-
For female subjects: pregnant or breast-feeding,
-
Subjects with solid tumors, for whom the Investigator has clinical suspicion of active
disease at the time of enrolment.
-
Legal incapacity or limited legal capacity.
Alter
>= 18 Jahre
Status
Rekrutierung beendet
Beginn der Rekrutierung
11.08.2009
Rekrutierende Länder
Frankreich
U.S.A
Studienleiter/in
Asatiani, MD, Ekaterine
Merck Serono S.A.,
E-Mail: [email protected]
Förderer
Merck
Registrierung in anderen
Studienregistern
ClinicalTrials.govNCT00957580 (primäres Register)
Anmerkung
contacts see: http://clinicaltrials.gov/ct2/show/NCT00957580
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 16.01.2017; Seite 2 von 2