Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001103-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).
It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.
Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I, NHL | Experimental | Participants in this NHL arm received multiple ascending doses between 50 and 2000 mg via intravenous infusion of obinutuzumab. |
|
| Phase I, CLL | Experimental | Participants in this CLL arm received multiple ascending doses between 400 and 2000 mg via intravenous infusion of obinutuzumab. |
|
| 400/400 mg - Phase II, iNHL | Experimental | Participants in this iNHL arm received an intravenous infusion of obinutuzumab 400 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 400 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. |
|
| 1600/800 mg - Phase II, iNHL | Experimental | Participants in this iNHL arm received an intravenous infusion of obinutuzumab 1600 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 800 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. |
|
| 400/400 mg - Phase II, aNHL | Experimental | Participants in this aNHL arm received an intravenous infusion of obinutuzumab 400 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 400 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab was provided in single-dose glass vials as a freeze-dried powder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study | Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab. | Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months) |
| Percentage of Participants With Best Overall Response in Phase II of the Study | Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) | by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study | A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients | at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Créteil | 94010 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31050355 | Derived | Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12. | |
| 26659915 |
Not provided
Not provided
Not provided
Different patients were recruited into Phase I and Phase II, and analyzed separately based on their disease. In this adaptive trial design, some of those same patients were included in follow-up even if they did not complete treatment, and 13 who had initially responded to treatment but subsequently progressed were retreated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 50-2000 mg Phase I, NHL | Obinutuzumab intravenous infusion |
| FG001 | 400-2000 mg Phase I, CLL | Obinutuzumab intravenous infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1600/800 mg - Phase II, aNHL | Experimental | Participants in this aNHL arm received an intravenous infusion of obinutuzumab 1600 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 800 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. |
|
| 1000/1000 mg - Phase II, CLL | Experimental | Participants in this CLL arm received an intravenous infusion of obinutuzumab 1000 mg on Days 1, 8, and 15 of Cycle 1 and obinutuzumab 1000 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days. |
|
| Retreated Participants | Experimental | Participants who might benefit from retreatment who were allowed to be treated again via intravenous infusion of obinutuzumab at the request of the investigator. |
|
|
| by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| Percentage of Participants With Partial Response (PR) in Phase II of the Study | A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites. | by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| Progression-free Survival (PFS) in Phase II of the Study | PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation. | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| Duration of Response by Disease Type in Phase II of the Study | Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation. | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| Participants With Event-Free Survival (EFS) in Phase II of the Study | EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first. | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study | B-cell depletion was defined in two ways: definition 1 - decrease below 5% baseline level and definition 2 - decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 - return to at least 50% of baseline level and definition 2 - return to at least 0.08 x 109/L. | by the end of Phase II (within 3 years, 4 months) |
| Percentage of Retreated Participants With Response | Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator. | by Cutoff Date: 25 November 2013 (within 4 years, 2 months) |
| Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants | Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses. | at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) |
| Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study | Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab. | Day 1 of Cycle 1 |
| Le Mans |
| 72015 |
| France |
| Lille | 59037 | France |
| Marseille | 13273 | France |
| Montpellier | 34295 | France |
| Nantes | 44093 | France |
| Paris | 75475 | France |
| Paris | 75651 | France |
| Pessac | 33604 | France |
| Pierre-Bénite | 69495 | France |
| Rennes | 35033 | France |
| Rouen | 76038 | France |
| Toulouse | 31059 | France |
| Tours | 37044 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Cologne | 50924 | Germany |
| Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11. |
| 25143487 | Derived | Cartron G, de Guibert S, Dilhuydy MS, Morschhauser F, Leblond V, Dupuis J, Mahe B, Bouabdallah R, Lei G, Wenger M, Wassner-Fritsch E, Hallek M. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood. 2014 Oct 2;124(14):2196-202. doi: 10.1182/blood-2014-07-586610. Epub 2014 Aug 20. |
| 23835718 | Derived | Morschhauser FA, Cartron G, Thieblemont C, Solal-Celigny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. doi: 10.1200/JCO.2012.46.9585. Epub 2013 Jul 8. |
| 23835715 | Derived | Salles GA, Morschhauser F, Solal-Celigny P, Thieblemont C, Lamy T, Tilly H, Gyan E, Lei G, Wenger M, Wassner-Fritsch E, Cartron G. Obinutuzumab (GA101) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2920-6. doi: 10.1200/JCO.2012.46.9718. Epub 2013 Jul 8. |
| 22431570 | Derived | Salles G, Morschhauser F, Lamy T, Milpied N, Thieblemont C, Tilly H, Bieska G, Asikanius E, Carlile D, Birkett J, Pisa P, Cartron G. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood. 2012 May 31;119(22):5126-32. doi: 10.1182/blood-2012-01-404368. Epub 2012 Mar 19. |
| FG002 | 400/400 mg - Phase II, iNHL | Obinutuzumab intravenous infusion |
| FG003 | 1600/800 mg - Phase II, iNHL | Obinutuzumab intravenous infusion |
| FG004 | 400/400 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| FG005 | 1600/800 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| FG006 | 1000/1000 mg - Phase II, CLL | Obinutuzumab intravenous infusion |
| Completed Treatment |
|
| Started Follow-up |
|
| Completed Follow-up |
|
| Retreated Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population: All enrolled participants who had received at least 1 dose of obinutuzumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 50-2000 mg Phase I, NHL | Obinutuzumab intravenous infusion |
| BG001 | 400-2000 mg Phase I, CLL | Obinutuzumab intravenous infusion |
| BG002 | 400/400 mg - Phase II, iNHL | Obinutuzumab intravenous infusion |
| BG003 | 1600/800 mg - Phase II, iNHL | Obinutuzumab intravenous infusion |
| BG004 | 400/400 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| BG005 | 1600/800 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| BG006 | 1000/1000 mg - Phase II, CLL | Obinutuzumab intravenous infusion |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study | Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab. | Safety population: All enrolled participants in Phase I, who had received at least 1 dose of obinutuzumab by 6 months. | Posted | Number | percentage of participants | Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Best Overall Response in Phase II of the Study | Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) | Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. | Posted | Number | percentage of participants | by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study | A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL. | Posted | Number | percentage of participants | by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Response (PR) in Phase II of the Study | A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites. | Posted | Number | percentage of participants | by Cutoff Date: 31 March 2012 (within 3 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Phase II of the Study | PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation. | Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. | Posted | Median | 95% Confidence Interval | days | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Disease Type in Phase II of the Study | Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation. | Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. Data reported for each disease cohort. | Posted | Median | Full Range | days | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Event-Free Survival (EFS) in Phase II of the Study | EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first. | Posted | Number | participants | by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study | B-cell depletion was defined in two ways: definition 1 - decrease below 5% baseline level and definition 2 - decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 - return to at least 50% of baseline level and definition 2 - return to at least 0.08 x 109/L. | Participants analyzed include those with B-cell depletion at the end of treatment (N), with assessments (n) at each time point. | Posted | Number | participants | by the end of Phase II (within 3 years, 4 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Retreated Participants With Response | Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator. | Retreated participants | Posted | Number | percentage of participants | by Cutoff Date: 25 November 2013 (within 4 years, 2 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants | Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses. | Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants at any of the given time points). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8. | Posted | Geometric Mean | Geometric Coefficient of Variation | µm/ml*day | at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study | Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab. | Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8. | Posted | Geometric Mean | Geometric Coefficient of Variation | µm/ml*day | Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/mL | at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) |
|
|
Through final cut off in November 2013
For frequency counts by preferred term, multiple occurrences of the same adverse event (AE) in an individual are counted only once.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | Safety-Evaluable Participants | 46 | 134 | 123 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiorespiratory arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Tooth avulsion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tumour lysis sydrome | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
Pharmacodynamic results were limited because number of participants was inversely proportional to length of follow-up. In other words, there were fewer participants still in the trial as the follow-up period became longer.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
Obinutuzumab intravenous infusion |
|
|
| OG003 | 1600/800 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| OG004 | 1000/1000 mg - Phase II, CLL | Obinutuzumab intravenous infusion |
|
|
Obinutuzumab intravenous infusion |
|
|
| OG002 | 400/400 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| OG003 | 1600/800 mg - Phase II, aNHL | Obinutuzumab intravenous infusion |
| OG004 | 1000/1000 mg - Phase II, CLL | Obinutuzumab intravenous infusion |
|
|
| OG002 | Phase II, CLL | Obinutuzumab intravenous infusion at 1000/1000 mg |
|
|
|
|
| OG004 | 1000/1000 mg - Phase II, CLL | Obinutuzumab intravenous infusion |
|
|
| Title | Denominators | Categories |
|---|
| Best overall response |
| |||||
| Complete response |
| |||||
| Partial response |
|
|
|
Obinutuzumab intravenous infusion |
|
|
|