Trial Outcomes & Findings for An Open Label Study of Oral Enzastaurin in Participants With Cancer (NCT NCT00309140)
NCT ID: NCT00309140
Last Updated: 2020-06-26
Results Overview
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline through study completion (up to 26 months and 30-day safety follow-up)
Results posted on
2020-06-26
Participant Flow
Eligible participants must have completed other enzastaurin clinical pharmacology studies to meet the enrollment criteria for the study.
Participant milestones
| Measure |
Enzastaurin
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Overall Study
STARTED
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23
|
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Overall Study
Received at Least 1 Dose of Study Drug
|
23
|
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Overall Study
COMPLETED
|
23
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Study of Oral Enzastaurin in Participants With Cancer
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Age, Continuous
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60.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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3 Participants
n=5 Participants
|
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Region of Enrollment
United States
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13 Participants
n=5 Participants
|
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Region of Enrollment
France
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10 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage I
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1 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage II
|
2 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage IIA
|
2 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage IIB
|
1 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage IIC
|
1 Participants
n=5 Participants
|
|
Disease Stage at Initial Pathological Diagnosis
Stage III
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3 Participants
n=5 Participants
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|
Disease Stage at Initial Pathological Diagnosis
Stage IV
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13 Participants
n=5 Participants
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|
Initial Pathological Diagnosis
Metastatic
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16 Participants
n=5 Participants
|
|
Initial Pathological Diagnosis
Locally Advanced
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5 Participants
n=5 Participants
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|
Initial Pathological Diagnosis
Other (Unspecified Cancer Diagnosis)
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2 Participants
n=5 Participants
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|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
0
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7 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
1
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13 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
2
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline through study completion (up to 26 months and 30-day safety follow-up)Population: All enrolled participants who received at least 1 dose of enzastaurin.
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
AEs
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19 Participants
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|
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
SAEs
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9 Participants
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SECONDARY outcome
Timeframe: Baseline through study completion (up to 26 months and 30-day safety follow-up)Population: All enrolled participants who received at least 1 dose of enzastaurin. Two (2) participants were censored.
Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Time to Disease Progression (Time to Documented Tumor Activity)
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1.4 months
Interval 1.1 to 3.1
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SECONDARY outcome
Timeframe: Baseline through study completion (up to 26 months and 30-day safety follow-up)Population: All enrolled participants who received at least 1 dose of enzastaurin.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Complete Response
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0 percentage of participants
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Partial Response
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0 percentage of participants
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Stable Disease
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34.8 percentage of participants
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Progressive Disease
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52.2 percentage of participants
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Unknown Response
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4.3 percentage of participants
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Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Missing Response
|
8.7 percentage of participants
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Adverse Events
Enzastaurin
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enzastaurin
n=23 participants at risk
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Gastrointestinal disorders
Ascites
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Gastrointestinal disorders
Oesophageal haemorrhage
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Gastrointestinal disorders
Vomiting
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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General disorders
Asthenia
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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General disorders
Chest pain
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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General disorders
General physical health deterioration
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Injury, poisoning and procedural complications
Post procedural haemorrhage
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Investigations
Transaminases increased
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Nervous system disorders
Aphasia
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Nervous system disorders
Hemiplegia
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
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4.3%
1/23 • Number of events 1
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Other adverse events
| Measure |
Enzastaurin
n=23 participants at risk
Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
|
|---|---|
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Gastrointestinal disorders
Abdominal pain upper
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
|
|
Gastrointestinal disorders
Constipation
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17.4%
4/23 • Number of events 4
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Gastrointestinal disorders
Nausea
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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General disorders
Fatigue
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Investigations
Blood alkaline phosphatase increased
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8.7%
2/23 • Number of events 4
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Investigations
Blood uric acid increased
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Investigations
Weight decreased
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13.0%
3/23 • Number of events 3
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Metabolism and nutrition disorders
Anorexia
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17.4%
4/23 • Number of events 4
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Nervous system disorders
Dizziness
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Psychiatric disorders
Insomnia
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8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • Number of events 2
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60