Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg |
Drug: CS-7017
CS-7017 administered orally, twice daily continuously for 6 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington | District of Columbia | United States |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
- Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS7017-A-U102E
Study Results
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 Detail | 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. |
| Arm/Group Title | CS-7017 0.75 mg BID | CS-7017 0.50 mg BID |
|---|---|---|
| Arm/Group Description | Participant who received oral CS-7017 0.75 mg twice daily (BID). | Participant who received oral CS-7017 0.50 mg twice daily (BID). |
| Period Title: Overall Study | ||
| STARTED | 1 | 1 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | CS-7017 0.50 mg BID | CS-7017 0.75 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | Participant who received oral CS-7017 0.50 mg twice daily (BID). | Participant who received oral CS-7017 0.75 mg twice daily (BID). | Total of all reporting groups |
| Overall Participants | 1 | 1 | 2 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
0
0%
|
1
100%
|
1
50%
|
| >=65 years |
1
100%
|
0
0%
|
1
50%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
72
(0)
|
42
(0)
|
57
(0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
1
100%
|
1
100%
|
2
100%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
100%
|
1
50%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
1
100%
|
0
0%
|
1
50%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
1
100%
|
2
100%
|
Outcome Measures
| Title | Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Best response was assessed in All Enrolled Participants. |
| Arm/Group Title | CS-7017 0.50 mg BID | CS-7017 0.75 mg BID |
|---|---|---|
| Arm/Group Description | Participant who received oral CS-7017 0.50 mg twice daily (BID). | Participant who received oral CS-7017 0.75 mg twice daily (BID). |
| Measure Participants | 1 | 1 |
| Partial response (PR) |
0
0%
|
1
100%
|
| Stable disease (SD) |
1
100%
|
0
0%
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Duration of response/stable disease and time to progression were assessed in All Enrolled Participants. |
| Arm/Group Title | CS-7017 0.50 mg BID | CS-7017 0.75 mg BID |
|---|---|---|
| Arm/Group Description | Participant who received oral CS-7017 0.50 mg twice daily (BID). | Participant who received oral CS-7017 0.75 mg twice daily (BID). |
| Measure Participants | 1 | 1 |
| Response duration |
NA
|
441
|
| Time to progression |
337
|
686
|
| Stable disease duration |
337
|
NA
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety events were assessed in the Safety Population. |
| Arm/Group Title | CS-7017 0.50 mg BID | CS-7017 0.75 mg BID |
|---|---|---|
| Arm/Group Description | Participant who received oral CS-7017 0.50 mg twice daily (BID). | Participant who received oral CS-7017 0.75 mg twice daily (BID). |
| Measure Participants | 1 | 1 |
| Grade 3 Hypercholesterolemia |
0
0%
|
1
100%
|
| Grade 1-2 Hypertriglyceridemia |
0
0%
|
1
100%
|
| Grade 1 Fatigue |
0
0%
|
1
100%
|
| Grade 3 Anaemia |
1
100%
|
0
0%
|
| Grade 1-2 Anaemia |
1
100%
|
0
0%
|
| Grade 1 Regurgitation |
1
100%
|
0
0%
|
| Grade 1 Tongue paralysis |
1
100%
|
0
0%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | CS-7017 0.50 mg BID | CS-7017 0.75 mg BID | ||
| Arm/Group Description | Participant who received oral CS-7017 0.50 mg twice daily (BID). | Participant who received oral CS-7017 0.75 mg twice daily (BID). | ||
All Cause Mortality |
||||
| CS-7017 0.50 mg BID | CS-7017 0.75 mg BID | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/1 (0%) | ||
Serious Adverse Events |
||||
| CS-7017 0.50 mg BID | CS-7017 0.75 mg BID | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| CS-7017 0.50 mg BID | CS-7017 0.75 mg BID | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 1/1 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/1 (100%) | 0/1 (0%) | ||
| Gastrointestinal disorders | ||||
| Regurgitation | 1/1 (100%) | 0/1 (0%) | ||
| Tongue paralysis | 1/1 (100%) | 0/1 (0%) | ||
| General disorders | ||||
| Fatigue | 0/1 (0%) | 1/1 (100%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercholesterolemia | 0/1 (0%) | 1/1 (100%) | ||
| Hypertriglceridemia | 0/1 (0%) | 1/1 (100%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Contact for Clinical Trial Information |
|---|---|
| Organization | Daiichi Sankyo |
| Phone | 908-992-6400 |
| CTRinfo@dsi.com |
- CS7017-A-U102E