Trial Outcomes & Findings for Chemotherapy for Participants With Lymphoma (NCT NCT00436280)
NCT ID: NCT00436280
Last Updated: 2020-08-06
Results Overview
PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.
COMPLETED
PHASE2
68 participants
First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year
2020-08-06
Participant Flow
Reasons reported are for discontinuation from study treatment.
Participant milestones
| Measure |
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease (PD)/Toxicity or up to 3 years.
|
|---|---|
|
Period 1: Induction
STARTED
|
68
|
|
Period 1: Induction
Received at Least 1 Dose of Study Drug
|
68
|
|
Period 1: Induction
COMPLETED
|
40
|
|
Period 1: Induction
NOT COMPLETED
|
28
|
|
Period 2: Consolidation
STARTED
|
40
|
|
Period 2: Consolidation
COMPLETED
|
23
|
|
Period 2: Consolidation
NOT COMPLETED
|
17
|
|
Period 3: Maintenance
STARTED
|
23
|
|
Period 3: Maintenance
COMPLETED
|
5
|
|
Period 3: Maintenance
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease (PD)/Toxicity or up to 3 years.
|
|---|---|
|
Period 1: Induction
Adverse Event
|
8
|
|
Period 1: Induction
Progressive Disease
|
12
|
|
Period 1: Induction
Stable Disease
|
6
|
|
Period 1: Induction
Withdrawal by Subject
|
1
|
|
Period 1: Induction
Death
|
1
|
|
Period 2: Consolidation
Adverse Event
|
1
|
|
Period 2: Consolidation
Progressive Disease
|
10
|
|
Period 2: Consolidation
Stable Disease
|
1
|
|
Period 2: Consolidation
Physician Decision
|
2
|
|
Period 2: Consolidation
Withdrawal by Subject
|
2
|
|
Period 2: Consolidation
Death
|
1
|
|
Period 3: Maintenance
Adverse Event
|
6
|
|
Period 3: Maintenance
Progressive Disease
|
12
|
Baseline Characteristics
Chemotherapy for Participants With Lymphoma
Baseline characteristics by cohort
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Age, Continuous
|
66.92 years
STANDARD_DEVIATION 12.468 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 YearPopulation: All randomized participants who received at least 1 dose of study drug. Participants censored =14
PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
|
16.4 percentage of participants
Interval 8.1 to 27.4
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 CyclesPopulation: All randomized participants who received at least 1 dose of study drug.
Assessment of response was based on the International Workshop to Standardize Response criteria for lymphoma (Cheson et al. 1999). CR is the complete disappearance of all detectable clinical and radiologic evidence of disease; all lymph nodes and nodal masses must have regressed to normal size (≤1.5 cm in their greatest transverse diameter for nodes \>1.5 cm before therapy).CRu is as CR but with 1 or more of the following features: A residual lymph node mass \>1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD) and/or indeterminate bone marrow with normalization of all biologic abnormalities. PR is regression of more than 50% (SPD) of all measurable lesions, disappearance of nonmeasurable lesions and no new lesion. For each response category the number of participants with this response will be divided by the total number of participants treated to achieve the response rate.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)
End of 4 cycles
|
50 percentage of participants
Interval 37.6 to 62.4
|
|
Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)
End of 8 cycles
|
52.50 percentage of participants
Interval 36.1 to 68.5
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 YearsPopulation: All randomized participants who received at least 1 dose of study drug. 8 participants were censored.
PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). PFS rate was defined as the rate of PFS at 2 year from the date of first dose of study drug and was determined using the distribution of overall PFS times. PFS rate was defined as the rate of PFS at 4 year from the date of first dose of study drug and was determined using the distribution of overall PFS times. For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of the last progression-free disease assessment.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment
2 Years
|
12.1 percentage of participants
Interval 5.5 to 21.6
|
|
Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment
4 Years
|
8.7 percentage of participants
Interval 3.3 to 17.4
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 YearsPopulation: All randomized participants who received at least 1 dose of study drug. 14 participants were censored.
Overall survival was defined as the time from the date of first dose of study drug to the date of death from any cause. For participants who were not still alive at the time of analysis, survival time was censored at the last contact date. For participants not known to have died as of the cut-off date for analysis,OS was censored at the last contact date for participants in post-discontinuation.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years
4 Years
|
20.9 percentage of participants
Interval 12.2 to 31.3
|
|
Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years
1 Year
|
52.3 percentage of participants
Interval 39.8 to 63.4
|
|
Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years
2 Years
|
29.9 percentage of participants
Interval 19.5 to 41.0
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 YearsPopulation: All randomized participants who received at least 1 dose of study drug. 6 participants were censored.
Event-free survival time was defined as the time from the date of first dose of study drug to the first date of measured PD,or start of a new treatment for the lymphoma, or death from any cause. For participants not known to have events as of the data cut-off date, EFS was censored at the date of the last tumor assessment.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=68 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years
1 Year
|
15.0 percentage of participants
Interval 7.7 to 24.5
|
|
Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years
2 Years
|
10.3 percentage of participants
Interval 4.4 to 19.0
|
|
Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years
4 Years
|
8.6 percentage of participants
Interval 3.3 to 17.0
|
SECONDARY outcome
Timeframe: Baseline, Cycles 1-4, End of StudyPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable samples.
PFS based on DLBCL molecular subtypes (GCB vs non-GCB) were determined. The molecular characterization of germinal center B-cells (GCBs) vs. non-GCBs was analyzed as separate combination immunohistochemistry (IHC) markers based on the Hans algorithms. Molecular subtype was included as class effect in the analytical models, adjusting for International Prognostic Index (IPI) score.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=31 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)
Non-GCB
|
4.7 months
Interval 2.0 to 7.3
|
|
Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)
GCB
|
7.8 months
Interval 1.0 to 12.1
|
SECONDARY outcome
Timeframe: Baseline, Cycles 1-4, End of StudyPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable samples.
Reported PFS was based on PKCB2 protein expression assessed by immunohistochemistry (scored in 10% increments for percent of tumor cells). Protein expression levels was grouped into high and low in association with the clinical endpoints. Grouping was based on 1) a pre-specified threshold provided by the pathologist at Cleveland Clinic for the diffuse large B-cell lymphoma (DLBCL)-prognostic markers, and 2) a median cut-point for the enzastaurin-specific markers.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=30 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)
Low Expression
|
6.1 months
Interval 1.8 to 7.9
|
|
PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)
High Expression
|
3.6 months
Interval 0.9 to 11.3
|
SECONDARY outcome
Timeframe: Day 2 of Cycle 2: Predose;1-2 Hours(H);3-4 h;5-6 h;7-8 H PostdosePopulation: All randomized participants who received at least 1 dose of study drug and evaluable PK data.
Cmax,ss is defined as the maximum observed drug concentration during a dosing interval at steady state. Non-Compartmental Pharmacokinetic Parameters for Total Analyte (Enzastaurin + LSN326020). LSN326020 is Enzastaurin's major active metabolite.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=15 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites]
|
2750 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 61
|
SECONDARY outcome
Timeframe: Day 2 of Cycle 2: Predose;1-2 hours(h);3-4 h;5-6 h;7-8 h PostdosePopulation: All randomized subjects who received at least 1 dose of study drug and evaluable PK data.
AUCτ,ss is defined as the area under the concentration versus time curve during 1 dosing interval at steady state.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=15 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte
|
44100 nanomoles*hour per liter(nmol•h/L)
Geometric Coefficient of Variation 70
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to Relapse after CR or CRu or Death from any Cause at 1 Year, 2 Years and 4 YearsPopulation: All randomized participants who received at least 1 dose of study drug. 7 participants were censored.
DFS was calculated as the duration from date of first dose of study drug to the date of first relapse event after CR or CRu or death from any cause. Participants who have not experienced an event at the time of analysis were censored at the most recent date of disease assessment. Events are relapse after a CR or CRu. Related death or death from unknown cause was considered as an event. Unrelated death was not considered as an event and the participant was censored at the time of death for this analysis. Unrelated death was defined as death from a cause not related to the lymphoma, any examination done for the lymphoma, or any treatment of the lymphoma.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=14 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years
1 Year
|
69.2 percentage of participants
Interval 37.3 to 87.2
|
|
Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years
2 Years
|
52.7 percentage of participants
Interval 23.4 to 75.5
|
|
Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years
4 Years
|
52.7 percentage of participants
Interval 23.4 to 75.5
|
SECONDARY outcome
Timeframe: Time from Observed CR and CRu or PR (Up to 4 Years)Population: All randomized participants who received at least 1 dose of study drug. Participants censored =13.
Duration of tumor response was defined as the time from the date when the measurement criteria were met for CR and CRu or PR (whichever status was recorded first) until the date of first observation of objective disease progression. For responding patients who died without objective PD (including death from study disease), duration of response was censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have objective PD, duration of response was censored at the date of the last objective progression-free disease assessment. For responding patients who received subsequent systemic anticancer therapy (after discontinuation from the study chemotherapy) prior to objectively determined disease progression, duration of response was censored at the date of the last objective progression-free disease assessment prior to post-discontinuation therapy.
Outcome measures
| Measure |
Enzastaurin + R-GEMOX
n=3 Participants
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
|
|---|---|
|
Duration of Tumor Response (DOR)
|
23.4 years
Interval 9.6 to 40.6
|
Adverse Events
Enzastaurin + R-GEMOX
Serious adverse events
| Measure |
Enzastaurin + R-GEMOX
n=68 participants at risk
enzastaurin: 1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
gemcitabine: 1000 mg/m2, IV, once, every two weeks, four to eight 2 week cycles
rituximab: 375 mg/m2, IV, once every 2 weeks, four to eight 2 week cycles
oxaliplatin: 100 mg/m2, IV, once every two weeks, four to eight 2 week cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/68 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/68 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/68 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
2/68 • Number of events 4
|
|
Cardiac disorders
Atrial flutter
|
1.5%
1/68 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/68 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • Number of events 1
|
|
Gastrointestinal disorders
Jejunitis
|
1.5%
1/68 • Number of events 2
|
|
General disorders
Death
|
1.5%
1/68 • Number of events 1
|
|
General disorders
Fatigue
|
1.5%
1/68 • Number of events 3
|
|
General disorders
General physical health deterioration
|
2.9%
2/68 • Number of events 9
|
|
General disorders
Pyrexia
|
7.4%
5/68 • Number of events 7
|
|
Immune system disorders
Drug hypersensitivity
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Infection
|
2.9%
2/68 • Number of events 2
|
|
Infections and infestations
Lung infection
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.9%
2/68 • Number of events 3
|
|
Infections and infestations
Septic shock
|
1.5%
1/68 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
1.5%
1/68 • Number of events 11
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/68 • Number of events 2
|
|
Infections and infestations
Viral infection
|
1.5%
1/68 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.5%
1/68 • Number of events 3
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.5%
1/68 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
1.5%
1/68 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/68 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.9%
2/68 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.5%
1/68 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/68 • Number of events 2
|
|
Nervous system disorders
Dysaesthesia
|
1.5%
1/68 • Number of events 8
|
|
Nervous system disorders
Hypogeusia
|
1.5%
1/68 • Number of events 8
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/68 • Number of events 2
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
1.5%
1/68 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/68 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/68 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.5%
1/68 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/68 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
2/68 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
1.5%
1/68 • Number of events 2
|
|
Vascular disorders
Thrombophlebitis
|
1.5%
1/68 • Number of events 2
|
Other adverse events
| Measure |
Enzastaurin + R-GEMOX
n=68 participants at risk
enzastaurin: 1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
gemcitabine: 1000 mg/m2, IV, once, every two weeks, four to eight 2 week cycles
rituximab: 375 mg/m2, IV, once every 2 weeks, four to eight 2 week cycles
oxaliplatin: 100 mg/m2, IV, once every two weeks, four to eight 2 week cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
34/68 • Number of events 115
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
34/68 • Number of events 109
|
|
Blood and lymphatic system disorders
Lymphopenia
|
36.8%
25/68 • Number of events 75
|
|
Blood and lymphatic system disorders
Neutropenia
|
61.8%
42/68 • Number of events 151
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
64.7%
44/68 • Number of events 188
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
7/68 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
19.1%
13/68 • Number of events 41
|
|
Gastrointestinal disorders
Diarrhoea
|
27.9%
19/68 • Number of events 40
|
|
Gastrointestinal disorders
Nausea
|
38.2%
26/68 • Number of events 58
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
14/68 • Number of events 23
|
|
General disorders
Asthenia
|
23.5%
16/68 • Number of events 51
|
|
General disorders
Fatigue
|
13.2%
9/68 • Number of events 30
|
|
General disorders
Mucosal inflammation
|
5.9%
4/68 • Number of events 5
|
|
General disorders
Oedema peripheral
|
14.7%
10/68 • Number of events 15
|
|
General disorders
Pyrexia
|
13.2%
9/68 • Number of events 14
|
|
Infections and infestations
Urinary tract infection
|
7.4%
5/68 • Number of events 8
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.9%
4/68 • Number of events 5
|
|
Investigations
Alanine aminotransferase increased
|
30.9%
21/68 • Number of events 59
|
|
Investigations
Aspartate aminotransferase increased
|
32.4%
22/68 • Number of events 74
|
|
Investigations
Blood creatinine increased
|
5.9%
4/68 • Number of events 17
|
|
Investigations
Blood lactate dehydrogenase increased
|
17.6%
12/68 • Number of events 42
|
|
Investigations
Weight decreased
|
11.8%
8/68 • Number of events 22
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
7/68 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
5/68 • Number of events 9
|
|
Nervous system disorders
Neuropathy peripheral
|
11.8%
8/68 • Number of events 40
|
|
Nervous system disorders
Paraesthesia
|
27.9%
19/68 • Number of events 97
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.7%
10/68 • Number of events 60
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
4/68 • Number of events 13
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60