Advanced Cancer
Conditions
Keywords
CS-7017, Advanced Cancer
Brief summary
This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.
Detailed description
This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.
Interventions
DRUGCS-7017
CS-7017 administered orally, twice daily continuously for 6 weeks
Sponsors
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.
Exclusion criteria
* Anticipation of need for a major surgical procedure or radiation therapy during the study. * Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure. * Participants with clinically significant pleural or pericardial effusions. * Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy. * Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer | From baseline and every 6 weeks postdose, up to 2 years 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and every 6 weeks postdose, up to 2 years 6 months | 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. |
| 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 | Baseline up to 30 days after last dose, up to 2 years 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CS-7017 0.50 mg BID Participant who received oral CS-7017 0.50 mg twice daily (BID). | 1 |
| CS-7017 0.75 mg BID Participant who received oral CS-7017 0.75 mg twice daily (BID). | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease progression | 1 | 1 |
Baseline characteristics
| Characteristic | CS-7017 0.75 mg BID | Total | CS-7017 0.50 mg BID |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 0 | 57 years STANDARD_DEVIATION 0 | 72 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
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).
Time frame: From baseline and every 6 weeks postdose, up to 2 years 6 months
Population: Best response was assessed in All Enrolled Participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-7017 0.50 mg 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 |
| CS-7017 0.50 mg BID | 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 |
| CS-7017 0.75 mg 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) | 1 Participants |
| CS-7017 0.75 mg BID | 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) | 0 Participants |
Secondary
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
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.
Time frame: Baseline and every 6 weeks postdose, up to 2 years 6 months
Population: Duration of response/stable disease and time to progression were assessed in All Enrolled Participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CS-7017 0.50 mg 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 |
| CS-7017 0.50 mg 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 | Time to progression | 337 days |
| CS-7017 0.50 mg 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 | Stable disease duration | 337 days |
| CS-7017 0.75 mg 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 | 441 days |
| CS-7017 0.75 mg 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 | Time to progression | 686 days |
| CS-7017 0.75 mg 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 | Stable disease duration | NA days |
Secondary
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
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.
Time frame: Baseline up to 30 days after last dose, up to 2 years 6 months
Population: Safety events were assessed in the Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-7017 0.50 mg 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 1 Fatigue | 0 Participants |
| CS-7017 0.50 mg 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 1-2 Anaemia | 1 Participants |
| CS-7017 0.50 mg 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 1-2 Hypertriglyceridemia | 0 Participants |
| CS-7017 0.50 mg 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 1 Regurgitation | 1 Participants |
| CS-7017 0.50 mg 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 Anaemia | 1 Participants |
| CS-7017 0.50 mg 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 1 Tongue paralysis | 1 Participants |
| CS-7017 0.50 mg 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 |
| CS-7017 0.75 mg 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 1 Tongue paralysis | 0 Participants |
| CS-7017 0.75 mg 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 | 1 Participants |
| CS-7017 0.75 mg 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 1-2 Hypertriglyceridemia | 1 Participants |
| CS-7017 0.75 mg 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 1 Fatigue | 1 Participants |
| CS-7017 0.75 mg 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 Anaemia | 0 Participants |
| CS-7017 0.75 mg 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 1-2 Anaemia | 0 Participants |
| CS-7017 0.75 mg 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 1 Regurgitation | 0 Participants |