Trial · NCT00881569
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
NCT00881569, Phase 1, Completed, Daiichi Sankyo; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017. Trials, record NCT00881569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00881569
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
- NCT number
- NCT00881569
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Advanced Cancer
- Interventions
- CS-7017
- First posted
- 2009-04-15
- Last updated
- 2020-09-28
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| 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 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Best response was assessed in All Enrolled Participants. | Participants | COUNT_OF_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 | Baseline and every 6 weeks postdose, up to 2 years 6 months | Duration of response/stable disease and time to progression were assessed in All Enrolled Participants. | days | NUMBER |
| 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 | Baseline up to 30 days after last dose, up to 2 years 6 months | Safety events were assessed in the Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer | CS-7017 0.50 mg BID | Partial response (PR) | 0 | Participants | |
| Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer | CS-7017 0.75 mg BID | Partial response (PR) | 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 | CS-7017 0.50 mg BID | Stable disease (SD) | 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 | CS-7017 0.75 mg BID | Stable disease (SD) | 0 | Participants | |
| 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 | CS-7017 0.50 mg BID | Response duration | NA | 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 | CS-7017 0.75 mg BID | Response duration | 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 | CS-7017 0.50 mg BID | Time to progression | 337 | 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 | CS-7017 0.75 mg BID | Time to progression | 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 | CS-7017 0.50 mg BID | Stable disease duration | 337 | 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 | CS-7017 0.75 mg BID | Stable disease duration | NA | days |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-7017 0.75 mg BID | 1 | |
| Overall Study | STARTED | CS-7017 0.50 mg BID | 1 | |
| Overall Study | COMPLETED | CS-7017 0.75 mg BID | 0 | |
| Overall Study | COMPLETED | CS-7017 0.50 mg BID | 0 | |
| Overall Study | NOT COMPLETED | CS-7017 0.75 mg BID | 1 | |
| Overall Study | NOT COMPLETED | CS-7017 0.50 mg BID | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypercholesterolemia | Metabolism and nutrition disorders | CS-7017 0.50 mg BID | 0 | 1 | |
| other | Hypercholesterolemia | Metabolism and nutrition disorders | CS-7017 0.75 mg BID | 1 | 1 | |
| other | Hypertriglceridemia | Metabolism and nutrition disorders | CS-7017 0.50 mg BID | 0 | 1 | |
| other | Hypertriglceridemia | Metabolism and nutrition disorders | CS-7017 0.75 mg BID | 1 | 1 | |
| other | Fatigue | General disorders | CS-7017 0.50 mg BID | 0 | 1 | |
| other | Fatigue | General disorders | CS-7017 0.75 mg BID | 1 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.50 mg BID | 1 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.75 mg BID | 0 | 1 | |
| other | Regurgitation | Gastrointestinal disorders | CS-7017 0.50 mg BID | 1 | 1 | |
| other | Regurgitation | Gastrointestinal disorders | CS-7017 0.75 mg BID | 0 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-7017 0.50 mg BID | 0 | 1 |
| Total, all-cause mortality | CS-7017 0.75 mg BID | 0 | 1 |
| Total, other adverse events | CS-7017 0.50 mg BID | 1 | 1 |
| Total, other adverse events | CS-7017 0.75 mg BID | 1 | 1 |
| Total, serious adverse events | CS-7017 0.50 mg BID | 0 | 1 |
| Total, serious adverse events | CS-7017 0.75 mg BID | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CS-7017 0.50 mg BID vs CS-7017 0.75 mg BID: deaths from any cause | Trial comparisons |
| CS-7017 0.50 mg BID vs CS-7017 0.75 mg BID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00881569
GET https://conductscience.org/api/trials/v1/NCT00881569/results?page=2