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A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

11. November 2015 aktualisiert von: Hoffmann-La Roche

A PHASE IB/II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VISMODEGIB IN RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) AND RELAPSED/REFRACTORY HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS)

This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in combination with cytarabine 20 mg subcutaneously for 10 days.

Anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

38

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
      • Braunschweig, Deutschland, 38114
      • Essen, Deutschland, 45122
      • Hamburg, Deutschland, 20246
      • Heidelberg, Deutschland, 69120
      • Münster, Deutschland, 48149
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6L5X8
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2M9
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
      • Montreal, Quebec, Kanada, H3T 1E2
  • Vereinigte Staaten
    • California
      • Stanford, California, Vereinigte Staaten, 94305
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64131
    • New York
      • New York, New York, Vereinigte Staaten, 10065
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with documented relapsed or refractory AML, except acute promyelocytic leukemia (APL [M3 subtype]), or relapsed or refractory high-risk MDS (high-risk MDS defined as International Prognostic Scoring System (IPSS) Int-2 or high and >/= 10% blasts in bone marrow)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Negative serum pregnancy test for women of childbearing potential and use of two forms of contraception while enrolled in the study and for 7 months after the patient discontinues from study
  • Male patients with female partners of childbearing potential must agree to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 2 months after the last dose of vismodegib
  • All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade </= 2 prior to starting therapy
  • Adequate hepatic and renal function

Exclusion Criteria:

  • Prior treatment with a Hh pathway inhibitor
  • Prior therapy for the treatment of malignancy within 14 days of Day 1, with the exception of:

Hydroxyurea in patients who need to continue this agent to maintain white blood cell (WBC) counts </= 50,000/mL. Hydroxyurea must be discontinued by Day 14 of the study

  • Current evidence of active central nervous system (CNS) leukemia
  • Any other active malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

Unstable angina, symptomatic or otherwise uncontrolled arrhythmia requiring medication (does not include stable, lone atrial fibrillation), or myocardial infarction </= 6 months before study treatment start Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study

  • Pregnant or breast-feeding women
  • Patients who refuse to potentially receive blood products and/or have a severe hypersensitivity to blood products

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Vismodegib
Arzneimittel: cytarabine
Cohort 2: 20 mg sc daily for 10 days starting Day 1, with a possible further cycle of 20 mg sc daily for 5 days starting no earlier than Day 29
Arzneimittel: vismodegib
Cohorts 1 and 2: 150 mg orally daily
Andere Namen:
  • RO5450815

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8
Zeitfenster: Week 8
CR was defined as achieved if the neutrophils count was greater than (>) 1000 cells per microliter (µL), platelets count >100000/µL, bone marrow blasts percentage (%) less than (<) 5, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of extra medullary disease (EMD). CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils >1000 cells/µL or Not applicable [NA] or platelets count >100000/µL or NA), bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods.
Week 8

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment
Zeitfenster: Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)
CR was defined as achieved if the neutrophils count >1000 cells/µL, platelets count >100000/µL, bone marrow blasts <5%, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of EMD. CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils > 1000 cells/µL or NA or platelets count >100000/µL or NA, bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods. The 95% confidence intervals (CI) were constructed using Blyth-Still-Cassella method.
Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)
Duration of Overall Response (DOR)
Zeitfenster: Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)
DOR is defined as the time from the first occurrence of a documented overall response to the time of relapse, as determined by the investigator using International Working Group (IWG) criteria (Participants not falling under any of the response criteria [CR or CRi or MLFS or PR] described under outcome measure 1 were considered as non-responders) or death from any cause during the study (defined as death within 30 days after the last dose of study drug).
Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)
Median Overall Survival (OS) Time
Zeitfenster: Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)
OS was defined as the time from start of study drug to death from any cause. OS was estimated using Kaplan-Meier analysis. Participants alive at the last date known to be alive were censored for the analysis.
Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)
Percentage of Participants With an Event of Death During the Study
Zeitfenster: Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)
Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)
Pharmacokinetics (PK): Steady-state Plasma Concentration of Vismodegib
Zeitfenster: Predose on Days 8, 29 and 57
PK data was planned to be reported only if the results of Cohort 2 are available.
Predose on Days 8, 29 and 57
Area Under the Concentration-time Curve (AUC) of Cytarabine
Zeitfenster: Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29
PK data was planned to be reported only if the results of Cohort 2 are available.
Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2013

Primärer Abschluss (Tatsächlich)

1. November 2014

Studienabschluss (Tatsächlich)

1. November 2014

Studienanmeldedaten

Zuerst eingereicht

11. Juni 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juni 2013

Zuerst gepostet (Schätzen)

19. Juni 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GO28852
  • 2013-001570-14 (EudraCT-Nummer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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