Trial · NCT00986440
Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
NCT00986440, Phase 2, Terminated, Daiichi Sankyo; results first posted 2020-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy. Trials, record NCT00986440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00986440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
- NCT number
- NCT00986440
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Colorectal Cancer
- Interventions
- CS-7017, Placebo
- First posted
- 2009-09-30
- Last updated
- 2020-11-05
- Results first posted
- 2020-11-05
- Limitations and caveats
Early termination was due to changes in the standard of care within the proposed market. The study was designed when patient monitoring and no treatment was an option that will not support a confirmatory Phase 3 study. No safety or efficacy concerns.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | 18 weeks postdose | Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | At 12, 24, and 30 weeks postdose | Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | At 3, 6, 9, and 12 months postdose | Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis. |
| Secondary | Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months | The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.0, 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 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 | Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months | Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. Duration of response was estimated using Kaplan Meier methods. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Baseline up to 30 days after last study dose, up to 3 years 3 months | A treatment-emergent adverse event (TEAE) was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | 18 weeks postdose | PFS was assessed in the Full Analysis Set. | percentage of participants | NUMBER |
| SECONDARY | Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | At 12, 24, and 30 weeks postdose | PFS was assessed in the Full Analysis Set. | percentage of participants | NUMBER |
| SECONDARY | Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | At 3, 6, 9, and 12 months postdose | OS was assessed in the Full Analysis Set. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months | Best overall response and objective response rate were assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months | Duration of response was assessed in the Full Analysis Set. Number Analyzed for each Row represents only the participants with CR or PR (confirmed and unconfirmed) and SD. | weeks | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Baseline up to 30 days after last study dose, up to 3 years 3 months | Adverse events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | CS-7017 0.5 mg | 39.86 | 95% Confidence Interval 23.5 to 55.7 | percentage of participants | |
| Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Placebo | 25.00 | 95% Confidence Interval 13.0 to 39.0 | percentage of participants | |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | CS-7017 0.5 mg | Progression-free survival at 12 weeks | 62.0 | 95% Confidence Interval 44.6 to 75.5 | percentage of participants |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Placebo | Progression-free survival at 12 weeks | 47.5 | 95% Confidence Interval 31.6 to 61.8 | percentage of participants |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | CS-7017 0.5 mg | Progression-free survival at 24 weeks | 29.9 | 95% Confidence Interval 15.4 to 45.9 | percentage of participants |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Placebo | Progression-free survival at 24 weeks | 15.0 | 95% Confidence Interval 6.1 to 27.6 | percentage of participants |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | CS-7017 0.5 mg | Progression-free survival at 30 weeks | 29.9 | 95% Confidence Interval 15.4 to 45.9 | percentage of participants |
| Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Placebo | Progression-free survival at 30 weeks | 12.5 | 95% Confidence Interval 4.6 to 24.6 | percentage of participants |
| Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | CS-7017 0.5 mg | Overall survival rate at 3 months | 100.0 | 95% Confidence Interval 100.0 to 100.0 | percentage of participants |
| Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy | Placebo | Overall survival rate at 3 months | 92.9 | 95% Confidence Interval 79.5 to 97.6 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-7017 0.5 mg | 41 | |
| Overall Study | STARTED | Placebo | 43 | |
| Overall Study | Randomized, But Not Dosed | CS-7017 0.5 mg | 0 | |
| Overall Study | Randomized, But Not Dosed | Placebo | 1 | |
| Overall Study | COMPLETED | CS-7017 0.5 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | CS-7017 0.5 mg | 41 | |
| Overall Study | NOT COMPLETED | Placebo | 43 |
Source ClinicalTrials.gov
Adverse events64
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 | Anaemia | Blood and lymphatic system disorders | CS-7017 0.5 mg | 15 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 42 | |
| other | Tachycardia | Cardiac disorders | CS-7017 0.5 mg | 3 | 41 | |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 42 | |
| other | Abdominal pain | Gastrointestinal disorders | CS-7017 0.5 mg | 4 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 9 | 42 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CS-7017 0.5 mg | 2 | 41 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 42 | |
| other | Constipation | Gastrointestinal disorders | CS-7017 0.5 mg | 3 | 41 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 42 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-7017 0.5 mg | 16 | 41 |
| Total, all-cause mortality | Placebo | 23 | 42 |
| Total, other adverse events | CS-7017 0.5 mg | 41 | 41 |
| Total, other adverse events | Placebo | 31 | 42 |
| Total, serious adverse events | CS-7017 0.5 mg | 6 | 41 |
| Total, serious adverse events | Placebo | 5 | 42 |
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 0.5 mg vs Placebo: deaths from any cause | Trial comparisons |
| CS-7017 0.5 mg vs Placebo: 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/NCT00986440
GET https://conductscience.org/api/trials/v1/NCT00986440/results?page=2