Trial Outcomes & Findings for Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017 (NCT NCT00881569)
NCT ID: NCT00881569
Last Updated: 2020-09-28
Results Overview
At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
COMPLETED
PHASE1
2 participants
From baseline and every 6 weeks postdose, up to 2 years 6 months
2020-09-28
Participant Flow
A total of 2 participants who met all inclusion and no exclusion criteria were enrolled in this extension study at 1 clinic site in the United States.
This extension study was designed to allow continuation of treatment in participants who demonstrated clinical benefit from previous treatment with CS-7017 in CS7017-A-U102 study.
Participant milestones
| Measure |
CS-7017 0.75 mg BID
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
CS-7017 0.50 mg BID
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
CS-7017 0.75 mg BID
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
CS-7017 0.50 mg BID
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
|---|---|---|
|
Overall Study
Disease progression
|
1
|
1
|
Baseline Characteristics
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Baseline characteristics by cohort
| Measure |
CS-7017 0.50 mg BID
n=1 Participants
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
CS-7017 0.75 mg BID
n=1 Participants
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 0 • n=5 Participants
|
42 years
STANDARD_DEVIATION 0 • n=7 Participants
|
57 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline and every 6 weeks postdose, up to 2 years 6 monthsPopulation: Best response was assessed in All Enrolled Participants.
At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
Outcome measures
| Measure |
CS-7017 0.50 mg BID
n=1 Participants
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
CS-7017 0.75 mg BID
n=1 Participants
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
|---|---|---|
|
Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Partial response (PR)
|
0 Participants
|
1 Participants
|
|
Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Stable disease (SD)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 6 weeks postdose, up to 2 years 6 monthsPopulation: Duration of response/stable disease and time to progression were assessed in All Enrolled Participants.
Duration of response was to be calculated as the date of progression minus the earliest date of complete response (CR) or partial response (PR), plus 1. The earliest date of CR or PR was to be taken from the earlier study (CS7017-A-U102). If any participant entered the study with stable disease (SD), then the duration of SD was to be calculated as the date of progression minus the date of first dose, plus 1. Time to progression was to be calculated as the date of progression minus the date of first dose of study medication in the earlier study, plus 1.
Outcome measures
| Measure |
CS-7017 0.50 mg BID
n=1 Participants
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
CS-7017 0.75 mg BID
n=1 Participants
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
|---|---|---|
|
Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Response duration
|
NA days
A complete response or partial response was not observed in this participant; therefore, this assessment was not applicable.
|
441 days
|
|
Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Time to progression
|
337 days
|
686 days
|
|
Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Stable disease duration
|
337 days
|
NA days
Stable disease was not observed in this participant; therefore, this assessment was not applicable.
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 2 years 6 monthsPopulation: Safety events were assessed in the Safety Population.
Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. AE intensity was assessed according to the following scale: Mild (Grade 1), Awareness of sign or symptom, but easily tolerated, ie, does not interfere with subject's usual function; Moderate (Grade 2), Discomfort enough to cause interference with usual activity; Severe (Grade 3), Incapacitating with inability to work or do usual activity, ie, interferes significantly with participant's usual function. Severe (Grade 3) AEs indicate worse outcomes.
Outcome measures
| Measure |
CS-7017 0.50 mg BID
n=1 Participants
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
CS-7017 0.75 mg BID
n=1 Participants
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
|---|---|---|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 3 Hypercholesterolemia
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 1-2 Hypertriglyceridemia
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 1 Fatigue
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 3 Anaemia
|
1 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 1-2 Anaemia
|
1 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 1 Regurgitation
|
1 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Grade 1 Tongue paralysis
|
1 Participants
|
0 Participants
|
Adverse Events
CS-7017 0.50 mg BID
CS-7017 0.75 mg BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CS-7017 0.50 mg BID
n=1 participants at risk
Participant who received oral CS-7017 0.50 mg twice daily (BID).
|
CS-7017 0.75 mg BID
n=1 participants at risk
Participant who received oral CS-7017 0.75 mg twice daily (BID).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypertriglceridemia
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Regurgitation
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Tongue paralysis
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place