Trial Outcomes & Findings for Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma (NCT NCT00088205)
NCT ID: NCT00088205
Last Updated: 2020-07-01
Results Overview
Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100.
COMPLETED
PHASE2
60 participants
Baseline through at least 3 cycles of treatment (28-day cycle)
2020-07-01
Participant Flow
Participant flow reports those participants who discontinued from study drug. Only participants without confirmed progressive disease at the 30-day post-therapy visit were assessed for progression by radiological method every 3 months until disease progression.
Participant milestones
| Measure |
Enzastaurin
500 milligrams (mg) oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
|
|---|---|
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Overall Study
STARTED
|
60
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
60
|
|
Overall Study
Efficacy Population
|
59
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Enzastaurin
500 milligrams (mg) oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Overall Study
Adverse Event
|
4
|
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Overall Study
Progressive Disease
|
51
|
|
Overall Study
Physician Decision
|
1
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Overall Study
Death Due to Study Disease
|
4
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Baseline Characteristics
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=60 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Age, Continuous
|
66.0 years
n=5 Participants
|
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Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
42 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
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|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
France
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
7 Participants
n=5 Participants
|
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Baseline B Symptoms
Low (0-1)
|
9 Participants
n=5 Participants
|
|
Baseline B Symptoms
Medium (2-3)
|
39 Participants
n=5 Participants
|
|
Baseline B Symptoms
High (4-5)
|
8 Participants
n=5 Participants
|
|
Baseline B Symptoms
Not available
|
4 Participants
n=5 Participants
|
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Participants with High Lactate Dehydrogenase (LDH)
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through at least 3 cycles of treatment (28-day cycle)Population: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug.
Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
|
35.6 percentage of participants
Interval 23.4 to 47.8
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SECONDARY outcome
Timeframe: Baseline to 22.01 monthsPopulation: Zero participants were analyzed as no participant achieved CR, CRu or PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or death due to any cause up to 22.01 monthsPopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored = 3.
PFS time was defined as the time from the date of enrollment to the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. Progression-free survival time was censored at the date of the last assessment visit for participants who were still alive and who had not had documented progressive disease.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Progression-Free Survival (PFS)
|
1.97 months
Interval 1.45 to 2.66
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SECONDARY outcome
Timeframe: Baseline to date of death from any cause at least up to 23.10 monthsPopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored = 39.
OS was defined as the time from the date of enrollment to the date of death due to any cause. For each participant who was not known to have died as of the data-inclusion cut-off date, OS was censored for that analysis at the date of the last assessment visit prior to the cut-off date.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Overall Survival (OS)
|
22.01 months
Interval 13.93 to
Upper limit of 95% Confidence Interval was not estimable due to high censoring rate.
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SECONDARY outcome
Timeframe: Date of progression or death due to any cause up to 22.01 monthsPopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and met criteria for CR, CRu, PR or SD. Participants censored = 2.
Duration of overall response for responders was measured from the date that measurement criteria were met for CR, CRu, PR or SD (whichever status occurred first) until the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas Guidelines, CR was defined as the disappearance of all lesions. CRu was the disappearance of clinical and radiographic evidence of disease, normal appearance of spleen and greater than 75% regression in lymph node mass. PR was defined as at least a 50% decrease in the six largest dominant nodes. SD was when the response was poorer than partial response with no new lesions consistent with progressive disease. Duration of response was censored at the date of the last assessment visit for responders who were still alive and had not had documented progressive disease.
Outcome measures
| Measure |
Enzastaurin
n=13 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response]
|
5.55 months
Interval 4.67 to 8.15
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SECONDARY outcome
Timeframe: Baseline to date of new treatment up to 23.10 monthsPopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored =16.
Time to new treatment was as the time from enrollment to the date new treatment for the cancer under study was initiated. Time to new treatment was censored at the date of the last assessment visit for participants who were not documented to have initiated a new treatment.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Time to New Treatment
|
3.52 months
Interval 2.37 to 4.04
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SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4 and 6 (28-day cycle)Population: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and had FACT-Lym assessed at baseline and Cycles 2, 4 and 6.
The B symptoms, tumor-related symptoms, participant functioning, and health-related quality of life were assessed with FACT-Lym v. 4. FACT-Lym v. 4 consists of 42 items with 5-point rating scales for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The lymphoma tumor - specific subscale consists of 15 items with a score ranging from 0-60. Fact-Lymphoma total score ranges from 0-168. A higher score represents better quality of life.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Physical Well-being- Baseline
|
22.45 units on a scale
Standard Deviation 4.298
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Physical Well-being- Cycle 2
|
22.06 units on a scale
Standard Deviation 4.49
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Physical Well-being- Cycle 4
|
22.15 units on a scale
Standard Deviation 4.52
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Physical Well-being- Cycle 6
|
21.6 units on a scale
Standard Deviation 3.406
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Social Family Well-being- Baseline
|
21.13 units on a scale
Standard Deviation 4.792
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Social Family Well-being- Cycle 2
|
20.32 units on a scale
Standard Deviation 6.165
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Social Family Well-being- Cycle 4
|
19.2 units on a scale
Standard Deviation 5.421
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Social Family Well-being- Cycle 6
|
21.26 units on a scale
Standard Deviation 4.021
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Emotional Well-being- Baseline
|
17.41 units on a scale
Standard Deviation 4.547
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Emotional Well-being- Cycle 2
|
17.65 units on a scale
Standard Deviation 4.953
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Emotional Well-being- Cycle 4
|
17.56 units on a scale
Standard Deviation 4.961
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Emotional Well-being- Cycle 6
|
17.25 units on a scale
Standard Deviation 5.514
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Functional Well-being- Baseline
|
16.38 units on a scale
Standard Deviation 5.768
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Functional Well-being- Cycle 2
|
16.56 units on a scale
Standard Deviation 6.05
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Functional Well-being- Cycle 4
|
16.17 units on a scale
Standard Deviation 4.076
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Functional Well-being- Cycle 6
|
17.43 units on a scale
Standard Deviation 4.871
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Lymphoma Subscale- Baseline
|
46.27 units on a scale
Standard Deviation 8.78
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Lymphoma Subscale- Cycle 2
|
46.01 units on a scale
Standard Deviation 8.841
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Lymphoma Subscale- Cycle 4
|
46.9 units on a scale
Standard Deviation 7.555
|
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Lymphoma Subscale- Cycle 6
|
46.8 units on a scale
Standard Deviation 8.108
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Fact-Lymphoma Total Score- Baseline
|
123.6 units on a scale
Standard Deviation 22.21
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Fact-Lymphoma Total Score- Cycle 2
|
122.6 units on a scale
Standard Deviation 23.8
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Fact-Lymphoma Total Score- Cycle 4
|
122 units on a scale
Standard Deviation 20.67
|
|
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Fact-Lymphoma Total Score- Cycle 6
|
124.3 units on a scale
Standard Deviation 21.92
|
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4 and 6Population: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and had EuroQol-5D assessed at baseline and Cycles 2, 4, and 6.
Overall health status and participant utility values were measured with the EuroQol-5D questionnaire. EuroQol-5D describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 levels: 1 (no problem), 2 (some problem), and 3 (extreme problem). The questionnaire records the level of problems on each of 5 dimensions and is converted into the EuroQol-5D index based on preference weights (Dolan 1997), where a score of 0.0 = death and 1.0 = perfect health.
Outcome measures
| Measure |
Enzastaurin
n=59 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Baseline
|
0.70 units on a scale
Standard Deviation 0.28
|
|
Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Cycle 2
|
0.76 units on a scale
Standard Deviation 0.19
|
|
Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Cycle 4
|
0.74 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Cycle 6
|
0.68 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for PKCβ expression analysis.
IHC staining of tumor samples was carried out to determine PKCβ expression. Staining intensity was measured on a semiquantitative scale of 0 (or negative) to 3 (high intensity). The final score combined the components of staining intensity and the percentage of positive cells and was defined as \[1 \* (percentage of cells staining at 1)\] + \[2 \* (percentage of cells staining at 2)\] + \[3 \* (percentage of cells staining at 3)\]. Score ≥100 and staining intensity ≥2 indicates high expression for PKCβ, while score \<100 and staining intensity ≤1 indicates low expression for PKCβ.
Outcome measures
| Measure |
Enzastaurin
n=18 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining
Score ≥100 and staining intensity ≥2
|
14 Participants
|
|
Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining
Score <100 and staining intensity ≤1
|
4 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for Ki-67 expression analysis.
IHC staining of tumor samples was carried out to determine Ki-67 expression. High expression is defined as the percentage of positive cells ≥40%.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
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|---|---|
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Number of Participants With High Ki-67 Expression by IHC Staining
|
4 Participants
|
SECONDARY outcome
Timeframe: Each cycle (28-day cycle) up to 21 cycles and 30-day follow-upPopulation: All enrolled participants who received at least 1 dose of study drug.
Data presented are the number of participants who experienced SAEs, AEs, deaths due to progressive disease (PD), and deaths due to AEs while on treatment and death during the 30-day post-treatment follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Enzastaurin
n=60 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
|
|---|---|
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Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
SAEs
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Other non-serious AEs
|
54 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Deaths due to PD
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Deaths due to AEs
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Deaths during 30-day follow-up
|
6 Participants
|
SECONDARY outcome
Timeframe: Cycles 1 [1-4 hours (h) and 4-8 h postdose], 2 (predose, 2-4 h and 6-8 h postdose), and 3 (predose and 2-8 h postdose) of Day 1 of each 28-day cyclePopulation: All enrolled participants who received at least 1 dose of study drug and had evaluable data for Cav,ss.
The Steady-state plasma concentrations of total analytes (enzastaurin plus its active metabolite, LSN326020) observed after once-daily dosing were evaluated using sparse sampling methodology.
Outcome measures
| Measure |
Enzastaurin
n=56 Participants
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
|
|---|---|
|
Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)
Enzastaurin
|
627 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 74.4
|
|
Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)
Total analytes
|
1160 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 58.4
|
Adverse Events
Enzastaurin
Serious adverse events
| Measure |
Enzastaurin
n=60 participants at risk
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
2/60 • Number of events 2 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Intestinal polyp
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Melaena
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
Asthenia
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
General physical health deterioration
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Erysipelas
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Fungal infection
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Lobar pneumonia
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Oesophageal candidiasis
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Nervous system disorders
Sciatica
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal lesion
|
1.7%
1/60 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
2/60 • Number of events 2 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
Other adverse events
| Measure |
Enzastaurin
n=60 participants at risk
500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
5/60 • Number of events 6 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
11.7%
7/60 • Number of events 8 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
5/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Ascites
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Constipation
|
6.7%
4/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
10/60 • Number of events 11 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
3/60 • Number of events 4 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
8/60 • Number of events 14 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
Asthenia
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
Fatigue
|
15.0%
9/60 • Number of events 9 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
Oedema peripheral
|
6.7%
4/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
General disorders
Pyrexia
|
11.7%
7/60 • Number of events 7 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Infections and infestations
Bronchitis
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Investigations
Haemoglobin
|
5.0%
3/60 • Number of events 4 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Investigations
Weight decreased
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
5/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
4/60 • Number of events 4 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
5/60 • Number of events 5 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Nervous system disorders
Headache
|
6.7%
4/60 • Number of events 4 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Renal and urinary disorders
Chromaturia
|
5.0%
3/60 • Number of events 3 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
5.6%
1/18 • Number of events 1 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
6/60 • Number of events 6 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.3%
11/60 • Number of events 11 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.7%
7/60 • Number of events 7 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.7%
7/60 • Number of events 7 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
|
Vascular disorders
Hypotension
|
6.7%
4/60 • Number of events 4 • From randomization through 21 cycles (28-day cycle) and 30-day follow-up
|
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