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Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

27. Oktober 2017 aktualisiert von: Pfizer

A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

81

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

  • Belgien
      • Gent, Belgien, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuizen UZ Gasthuisberg
      • Wilrijk, Belgien, 2610
        • Oncologisch Centrum GZA - Location St. Augustinus
  • Deutschland
      • Berlin, Deutschland, 10117
        • Charite Campus Mitte
      • Berlin, Deutschland, 13353
        • Charité Berlin-Campus Virchow-Klinikum
  • Hongkong
      • Shatin, N.T., Hongkong
        • The Chinese University of Hong Kong, Prince of Wales Hospital
  • Japan
      • Aichi, Japan, 466-8650
        • Nagoya Daini Red Cross Hospital
      • Aichi, Japan, 460-0003
        • EPMint Co., Ltd
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan
        • National Hp. Org. Kyushu Medical Center
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Inst. Hp. of Japanese Foundation for Cancer Research
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, Republik von
    • Korea
      • Seoul, Korea, Korea, Republik von, 135-710
        • Samsung Medical Center
  • Niederlande
      • Rotterdam, Niederlande, 3015 CE
        • Erasmus Medisch Centrum
      • Rotterdam, Niederlande, 3015 GD
        • Erasmus MC Apotheek
  • Singapur
      • Singapore, Singapur, 169 608
        • Singapore General Hospital
  • Ungarn
      • Debrecen, Ungarn, 4012
        • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
      • Kaposvar, Ungarn, 7400
        • Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294-3300
        • University of Alabama Birmingham
      • Birmingham, Alabama, Vereinigte Staaten, 35294-3330
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Vereinigte Staaten, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Loma Linda, California, Vereinigte Staaten, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, Vereinigte Staaten, 92350 1700
        • Loma Linda University Cancer Center
      • Loma Linda, California, Vereinigte Staaten, 92354
        • Loma Linda University Cancer Center #5
      • Mission Hills, California, Vereinigte Staaten, 91345
        • Facey Medical Group
      • Mission Hills, California, Vereinigte Staaten, 91345
        • Providence Holy Cross
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush University Medical Center
    • Minnesota
      • Saint Louis Park, Minnesota, Vereinigte Staaten, 55426
        • Park Nicollet Frauenshuh Cancer Center
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Vereinigte Staaten, 63110
        • Barnes-Jewish Hospital
    • New Jersey
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • John Theurer Cancer Center
    • New York
      • Hawthorne, New York, Vereinigte Staaten, 10532
        • New York Medical College
    • Pennsylvania
      • Allentown, Pennsylvania, Vereinigte Staaten, 18103-6205
        • Quest Diagnostics
      • Carlisle, Pennsylvania, Vereinigte Staaten, 17015
        • Carlisle Regional Medical Center Lab
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033-0850
        • Penn State Milton S. Hershey Medical Center
      • Lewistown, Pennsylvania, Vereinigte Staaten, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
        • Fox Chase Cancer Center
      • State College, Pennsylvania, Vereinigte Staaten, 16803
        • CMSA Medical Lab
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030-4009
        • University of Texas, MD Anderson Cancer Center

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:

  • Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
  • Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
  • Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

  • History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
  • Prior allogeneic hematopoietic stem cell transplant (HSCT).
  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: inotuzumab ozogamicin
Arzneimittel: Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Andere Namen:
  • inotuzumab ozogamicin

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of Response in Participants With Indolent NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
Zeitfenster: 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Duration of Response in Participants With Follicular NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
Zeitfenster: 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL
Zeitfenster: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL
Zeitfenster: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL
Zeitfenster: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL
Zeitfenster: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL
Zeitfenster: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
6, 12 and 24 months
Kaplan-Meier Estimate of the OS in Participants With Follicular NHL
Zeitfenster: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL
Zeitfenster: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
6, 12 and 24 months
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)
Zeitfenster: Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit
Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL
Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Zeitfenster: Protocol reporting period: from informed consent to at least 28 days after the last dose.
Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.
Protocol reporting period: from informed consent to at least 28 days after the last dose.
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)
Zeitfenster: Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.
Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.

Mitarbeiter und Ermittler

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

Sponsor

Pfizer

Mitarbeiter

UCB Pharma

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

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 (Tatsächlich)

30. Juli 2009

Primärer Abschluss (Tatsächlich)

10. Januar 2012

Studienabschluss (Tatsächlich)

27. Juni 2013

Studienanmeldedaten

Zuerst eingereicht

24. März 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. März 2009

Zuerst gepostet (Schätzen)

25. März 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Oktober 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Oktober 2017

Zuletzt verifiziert

1. Oktober 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 3129K7-2001
  • B1931007 (Andere Kennung: Alias Study Number)
  • 2008-001635-34 (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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