Trial · NCT01199055
CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
NCT01199055, Phase 1, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC). Trials, record NCT01199055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199055
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT01199055
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- CS-7017, Carboplatin, Paclitaxel
- First posted
- 2010-09-10
- Last updated
- 2020-07-07
- Results first posted
- 2020-07-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D). |
| Primary | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). |
| Primary | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). |
| Primary | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to end of Cycle 1, with each treatment cycle being 3 weeks | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. |
| Secondary | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Baseline up to Week 18 postdose | The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to 30 days after last dose, up to approximately 1 year | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship. |
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 | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*h/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | h | MEDIAN |
| PRIMARY | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to end of Cycle 1, with each treatment cycle being 3 weeks | TEAEs were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Baseline up to Week 18 postdose | Best overall response and objective response rate were assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to 30 days after last dose, up to approximately 1 year | CS-7017-related TEAEs were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group149
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.25 mg BID; Initial Portion | Cycle 1, Week 1: AUCtau | 70.66 | Standard Deviation 54.11 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Initial Portion | Cycle 1, Week 1: AUCtau | 209.33 | Standard Deviation 131.40 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Additional Portion | Cycle 1, Week 1: AUCtau | 203.99 | Standard Deviation 91.34 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.25 mg BID; Initial Portion | Cycle 1, Week 1: AUClast | 49.57 | Standard Deviation 36.86 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Initial Portion | Cycle 1, Week 1: AUClast | 87.23 | Standard Deviation 85.69 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Additional Portion | Cycle 1, Week 1: AUClast | 81.54 | Standard Deviation 66.01 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.25 mg BID; Initial Portion | Cycle 2, Week 4: AUCtau | 132.47 | Standard Deviation 25.49 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Initial Portion | Cycle 2, Week 4: AUCtau | 345.56 | Standard Deviation 156.29 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.50 mg BID; Additional Portion | Cycle 2, Week 4: AUCtau | 400.89 | Standard Deviation 212.22 | ng*h/mL |
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | CS-7017 0.25 mg BID; Initial Portion | Cycle 2, Week 4: AUClast | 95.94 | Standard Deviation 15.84 | ng*h/mL |
1 to 10 of 149Source ClinicalTrials.gov
See all 149 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-7017 0.25 mg BID; Initial Portion | 3 | |
| Overall Study | STARTED | CS-7017 0.50 mg BID; Initial Portion | 4 | |
| Overall Study | STARTED | CS-7017 0.50 mg BID; Additional Portion | 9 | |
| Overall Study | COMPLETED | CS-7017 0.25 mg BID; Initial Portion | 1 | |
| Overall Study | COMPLETED | CS-7017 0.50 mg BID; Initial Portion | 1 | |
| Overall Study | COMPLETED | CS-7017 0.50 mg BID; Additional Portion | 5 | |
| Overall Study | NOT COMPLETED | CS-7017 0.25 mg BID; Initial Portion | 2 | |
| Overall Study | NOT COMPLETED | CS-7017 0.50 mg BID; Initial Portion | 3 | |
| Overall Study | NOT COMPLETED | CS-7017 0.50 mg BID; Additional Portion | 4 |
Source ClinicalTrials.gov
Adverse events87
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 | Upper respiratory tract infection | Infections and infestations | CS-7017 0.25 mg BID; Initial Portion | 2 | 3 | |
| other | Upper respiratory tract infection | Infections and infestations | CS-7017 0.50 mg BID; Initial Portion | 0 | 4 | |
| other | Upper respiratory tract infection | Infections and infestations | CS-7017 0.50 mg BID; Additional Portion | 0 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | CS-7017 0.25 mg BID; Initial Portion | 3 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | CS-7017 0.50 mg BID; Initial Portion | 3 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | CS-7017 0.50 mg BID; Additional Portion | 9 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.25 mg BID; Initial Portion | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.50 mg BID; Initial Portion | 3 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | CS-7017 0.50 mg BID; Additional Portion | 8 | 9 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CS-7017 0.25 mg BID; Initial Portion | 2 | 3 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-7017 0.25 mg BID; Initial Portion | 0 | 3 |
| Total, all-cause mortality | CS-7017 0.50 mg BID; Initial Portion | 1 | 4 |
| Total, all-cause mortality | CS-7017 0.50 mg BID; Additional Portion | 0 | 9 |
| Total, other adverse events | CS-7017 0.25 mg BID; Initial Portion | 3 | 3 |
| Total, other adverse events | CS-7017 0.50 mg BID; Initial Portion | 4 | 4 |
| Total, other adverse events | CS-7017 0.50 mg BID; Additional Portion | 9 | 9 |
| Total, serious adverse events | CS-7017 0.25 mg BID; Initial Portion | 2 | 3 |
| Total, serious adverse events | CS-7017 0.50 mg BID; Initial Portion | 1 | 4 |
| Total, serious adverse events | CS-7017 0.50 mg BID; Additional Portion | 6 | 9 |
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 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/NCT01199055
GET https://conductscience.org/api/trials/v1/NCT01199055/results?page=2