Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
27. října 2017 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
81
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Gent, Belgie, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgie, 3000
- Universitaire Ziekenhuizen UZ Gasthuisberg
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Wilrijk, Belgie, 2610
- Oncologisch Centrum GZA - Location St. Augustinus
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Rotterdam, Holandsko, 3015 CE
- Erasmus Medisch Centrum
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Rotterdam, Holandsko, 3015 GD
- Erasmus MC Apotheek
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Shatin, N.T., Hongkong
- The Chinese University of Hong Kong, Prince of Wales Hospital
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Aichi, Japonsko, 466-8650
- Nagoya Daini Red Cross Hospital
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Aichi, Japonsko, 460-0003
- EPMint Co., Ltd
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Fukuoka, Japonsko, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Fukuoka, Japonsko
- National Hp. Org. Kyushu Medical Center
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Kanagawa, Japonsko, 259-1193
- Tokai University Hospital
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Tokyo, Japonsko, 135-8550
- Cancer Inst. Hp. of Japanese Foundation for Cancer Research
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Chiba
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Kashiwa, Chiba, Japonsko, 277-8577
- National Cancer Center Hospital East
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Tokyo
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Chuo-ku, Tokyo, Japonsko, 104-0045
- National Cancer Center Hospital
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Korea
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Seoul, Korea, Korejská republika, 135-710
- Samsung Medical Center
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Debrecen, Maďarsko, 4012
- Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
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Kaposvar, Maďarsko, 7400
- Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
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Berlin, Německo, 10117
- Charité Campus Mitte
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Berlin, Německo, 13353
- Charité Berlin-Campus Virchow-Klinikum
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Singapore, Singapur, 169 608
- Singapore General Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-3300
- University of Alabama Birmingham
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Birmingham, Alabama, Spojené státy, 35294-3330
- University of Alabama at Birmingham
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Loma Linda, California, Spojené státy, 92354
- Loma Linda University Medical Center
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Loma Linda, California, Spojené státy, 92350 1700
- Loma Linda University Cancer Center
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Loma Linda, California, Spojené státy, 92354
- Loma Linda University Cancer Center #5
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Mission Hills, California, Spojené státy, 91345
- Facey Medical Group
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Mission Hills, California, Spojené státy, 91345
- Providence Holy Cross
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Rush University Medical Center
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Minnesota
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Saint Louis Park, Minnesota, Spojené státy, 55426
- Park Nicollet Frauenshuh Cancer Center
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Spojené státy, 63110
- Barnes-Jewish Hospital
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
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Hackensack, New Jersey, Spojené státy, 07601
- John Theurer Cancer Center
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New York
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Hawthorne, New York, Spojené státy, 10532
- New York Medical College
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18103-6205
- Quest Diagnostics
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Carlisle, Pennsylvania, Spojené státy, 17015
- Carlisle Regional Medical Center Lab
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Milton S. Hershey Medical Center
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Lewistown, Pennsylvania, Spojené státy, 17044
- Lewistown Hospital
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Philadelphia, Pennsylvania, Spojené státy, 19111-2497
- Fox Chase Cancer Center
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State College, Pennsylvania, Spojené státy, 16803
- CMSA Medical Lab
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Texas
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Houston, Texas, Spojené státy, 77030-4009
- University of Texas, MD Anderson Cancer Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: inotuzumab ozogamicin
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Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
Časové okno: 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.
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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.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Časové okno: 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.
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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.
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Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Časové okno: 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.
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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.
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Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Časové okno: 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.
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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.
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Duration of Response in Participants With Indolent NHL
Časové okno: 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.
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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.
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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.
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Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
Časové okno: 6, 12 and 24 months
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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.
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6, 12 and 24 months
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Duration of Response in Participants With Follicular NHL
Časové okno: 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.
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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.
|
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Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
Časové okno: 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.
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6, 12 and 24 months
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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
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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
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|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Časové okno: Protocol reporting period: from informed consent to at least 28 days after the last dose.
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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.
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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)
Časové okno: 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.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. července 2009
Primární dokončení (Aktuální)
10. ledna 2012
Dokončení studie (Aktuální)
27. června 2013
Termíny zápisu do studia
První předloženo
24. března 2009
První předloženo, které splnilo kritéria kontroly kvality
24. března 2009
První zveřejněno (Odhad)
25. března 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
31. října 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. října 2017
Naposledy ověřeno
1. října 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3129K7-2001
- B1931007 (Jiný identifikátor: Alias Study Number)
- 2008-001635-34 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .