Trial · NCT00408434
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
NCT00408434, Phase 1, Completed, Daiichi Sankyo; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer. Trials, record NCT00408434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00408434
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
- NCT number
- NCT00408434
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Neoplasm
- Interventions
- CS-7017
- First posted
- 2006-12-07
- Last updated
- 2020-10-19
- Results first posted
- 2020-10-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months | Complete response (CR) was defined as a disappearance of all target lesions, partial response (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). Objective response rate was defined as the sum of all CRs and PRs. |
| Secondary | Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Area under the plasma/serum drug concentration-time curve for dosing interval (AUC\[0-tau\]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC\[0-t\]) calculated using the linear trapezoidal rule were assessed. |
| Secondary | Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Cmax was defined as observed maximum plasma concentration. |
| Secondary | Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | |
| Secondary | Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Tmax was defined as time of maximum plasma concentration. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months | Best overall response was assessed in the Efficacy Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. | ng*h/ml | MEAN |
| SECONDARY | Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. | ng/ml | MEAN |
| SECONDARY | Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. | hour | MEAN |
| SECONDARY | Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. | hour | MEAN |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.10 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.15 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.25 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.35 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.50 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.75 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 1.15 mg | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 All Participants | Complete response (CR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.10 mg | Partial response (PR) | 0 | Participants | |
| Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies | CS-7017 0.15 mg | Partial response (PR) | 0 | Participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-7017 0.10 mg | 6 | |
| Overall Study | STARTED | CS-7017 0.15 mg | 3 | |
| Overall Study | STARTED | CS-7017 0.25 mg | 6 | |
| Overall Study | STARTED | CS-7017 0.35 mg | 3 | |
| Overall Study | STARTED | CS-7017 0.50 mg | 6 | |
| Overall Study | STARTED | CS-7017 0.75 mg | 3 | |
| Overall Study | STARTED | CS-7017 1.15 mg | 4 | |
| Overall Study | COMPLETED | CS-7017 0.10 mg | 0 | |
| Overall Study | COMPLETED | CS-7017 0.15 mg | 0 | |
| Overall Study | COMPLETED | CS-7017 0.25 mg | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events266
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 0.10 mg | 4 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.15 mg | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.25 mg | 6 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.35 mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.50 mg | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.75 mg | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 1.15 mg | 1 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | CS-7017 0.10 mg | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | CS-7017 0.15 mg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | CS-7017 0.25 mg | 1 | 6 |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-7017 0.10 mg | 0 | 6 |
| Total, all-cause mortality | CS-7017 0.15 mg | 0 | 3 |
| Total, all-cause mortality | CS-7017 0.25 mg | 0 | 6 |
| Total, all-cause mortality | CS-7017 0.35 mg | 2 | 3 |
| Total, all-cause mortality | CS-7017 0.50 mg | 0 | 6 |
| Total, all-cause mortality | CS-7017 0.75 mg | 0 | 3 |
| Total, all-cause mortality | CS-7017 1.15 mg | 0 | 4 |
| Total, other adverse events | CS-7017 0.10 mg | 6 | 6 |
| Total, other adverse events | CS-7017 0.15 mg | 3 | 3 |
| Total, other adverse events | CS-7017 0.25 mg | 6 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22570147 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00408434
GET https://conductscience.org/api/trials/v1/NCT00408434/results?page=2