Trial Outcomes & Findings for A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma (NCT NCT00744991)
NCT ID: NCT00744991
Last Updated: 2020-10-19
Results Overview
Response rate is percentage of participants with confirmed CR or PR as per modified Severity-Weighted Assessment Tool (mSWAT) for MF group; mSWAT and Sezary count for SS group. mSWAT is a weighted sum of percent (%) of total body surface area attributed to skin lesions which yield a mSWAT score \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response rate is calculated as total number of participants with CR or PR from the start of study treatment until PD or recurrence divided by the number of participants treated, then multiplied by 100.
COMPLETED
PHASE2
25 participants
Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]
2020-10-19
Participant Flow
This study had 2 stages. Stage 2 would occur if the minimum level of efficacy (confirmed complete or partial anti-tumor response) was observed in Stage 1. The study was considered complete at the end of Stage 1.
Participant milestones
| Measure |
Enzastaurin
Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
Received at Least 1 Dose
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Enzastaurin
Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
|
Overall Study
Progressive Disease
|
11
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Entry Criteria Unmet
|
1
|
Baseline Characteristics
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=25 Participants
Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
|
Number of Participants with Cutaneous T-Cell Lymphoma (CTCL) Variant
Mycosis Fungoides (MF)
|
19 Participants
n=5 Participants
|
|
Number of Participants with Cutaneous T-Cell Lymphoma (CTCL) Variant
Sezary Syndrome (SS)
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]Population: All participants who received at least 1 dose of study drug.
Response rate is percentage of participants with confirmed CR or PR as per modified Severity-Weighted Assessment Tool (mSWAT) for MF group; mSWAT and Sezary count for SS group. mSWAT is a weighted sum of percent (%) of total body surface area attributed to skin lesions which yield a mSWAT score \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response rate is calculated as total number of participants with CR or PR from the start of study treatment until PD or recurrence divided by the number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=19 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
n=6 Participants
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
Partial Response (PR)
|
5.3 percentage of participants
Interval 0.1 to 26.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
Complete Response (CR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Time of response to PD [up to 9 cycles (28-day cycles)]Population: Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR.
Time from first confirmed response \[Complete Response (CR) or Partial Response (PR)\] until Progressive Disease (PD) as per mSWAT for MF group; mSWAT and Sezary count for SS group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% reduction in mSWAT score from baseline; PD: ≥25% of mSWAT score from nadir). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline; PD: ≥40% of Sezary cells from nadir). Responders or those who died without PD were censored at date of last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at date of last progression-free disease assessment prior to post-discontinuation therapy.
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=1 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Duration of Response for Responding Participants
|
141 days
Only 1 participant was analyzed, therefore actual value was reported and the 95% confidence interval was not applicable.
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured PD [up to 9 cycles (28-day cycles)]Population: All participants who received at least 1 dose of study drug. Ten (10) participants were censored for MF group and 2 participants were censored for SS group for this analysis.
Elapsed time from enrollment (baseline) to date of Progressive Disease (PD) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed to responses. PD: ≥25% of mSWAT score from nadir. Sezary cells percentage in lymphocytes measured using flow cytometry. PD: ≥40% Sezary cells from nadir. Responders or those who died without PD were censored at the date of the last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at the date of the last progression-free disease assessment prior to post-discontinuation therapy.
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=19 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
n=6 Participants
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Time to Progression
|
78 days
Interval 50.0 to 107.0
|
44 days
Interval 4.0 to 82.0
|
SECONDARY outcome
Timeframe: Baseline to confirmed response [up to 9 cycles (28-day cycles)]Population: Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR.
Elapsed time from date of study enrollment (baseline) to first evidence of Complete Response (CR) or Partial Response (PR) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks. PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response must be confirmed, but the time to objective response ended at the first assessment. Participants who were not confirmed responders did not contribute to the time to objective response calculation.
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=1 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Time to Objective Response for Responding Participants
|
50 days
Only 1 participant was analyzed, therefore actual value was reported and the 95% confidence interval was not applicable.
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reportedPopulation: Enrolled participants who had a baseline and at least 1 post-baseline EQ-5D observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.
EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (1 (no problem), 2 (some problems), and 3 (extreme problems)). These combinations of attributes were converted into a single summary health-state index score by applying weights from the US-specific value set to the scoring algorithm. The EQ-5D US value set of health state index scores ranged from 0 (worst imagined health state) to 1 (best imagined health state).
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=25 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Utility Score United States (US) Index (Participant-Reported Measure of Health-State Utility)
|
0.7 units on a scale
Standard Deviation 0.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reportedPopulation: Enrolled participants who had a baseline and at least 1 post-baseline pruritus assessment observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.
Participants assessed their present level of itch through the use of an 11-point numeric rating scale anchored at 0 (no itch) and 10 (itch as bad as can be imagined).
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=25 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus)
|
5.0 units on a scale
Standard Deviation 3.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to study completion [up to 9 cycles (28-day cycles)], end of treatment reportedPopulation: Enrolled participants who had a baseline and at least 1 post-baseline Itchy QoL observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.
The Itchy QoL is a non-validated 22-item questionnaire designed to assess pruritus-associated symptoms with a 7-day recall using 3 domains: Emotions (9 items), Functions (7 items) and Symptoms domain (6 items). Each Itchy QoL item was evaluated by level of itch frequency through the use of a 5-point adjectival scale 1 (never), 2 (rarely), 3 (sometimes), 4 (often), 5 (all the time). Unweighted means were calculated individually for the 3 domains each with scores range from 1 to 5 and the total score is expressed as the mean of the three dimension scores and ranges from 1 (no itch) to 5 (worst imaginable itch).
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=20 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus)
Symptoms Domain
|
-0.02 units on a scale
Standard Deviation 0.78
|
—
|
|
Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus)
Emotions Domain
|
-0.09 units on a scale
Standard Deviation 0.63
|
—
|
|
Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus)
Functions Domain
|
0.23 units on a scale
Standard Deviation 0.69
|
—
|
|
Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus)
Total Score
|
0.03 units on a scale
Standard Deviation 0.59
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion [up to 9 cycles (28-day cycles)] plus 30-day safety follow-upPopulation: Participants who received at least 1 dose of study drug.
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Mycosis Fungoides (MF)
n=25 Participants
Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
Sezary Syndrome (SS)
Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin)
AEs
|
20 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin)
SAEs
|
5 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin)
Death due to progressive disease
|
1 Participants
|
—
|
Adverse Events
Enzastaurin
Serious adverse events
| Measure |
Enzastaurin
n=25 participants at risk
Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Bacteraemia
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Genital herpes
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
International normalised ratio increased
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Mental status changes
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
Other adverse events
| Measure |
Enzastaurin
n=25 participants at risk
Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.0%
6/25 • Number of events 7
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
3/25 • Number of events 4
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Fatigue
|
24.0%
6/25 • Number of events 6
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema peripheral
|
20.0%
5/25 • Number of events 5
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Staphylococcal infection
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Reproductive system and breast disorders
Prostatic pain
|
8.3%
1/12 • Number of events 1
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Number of events 2
Study-specific clinical outcomes due to Progressive Disease (PD) were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60