Carcinoma, Non-Small-Cell LungPhase 1NCT01199055

CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

A Phase 1 study testing CS-7017, Carboplatin and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Daiichi Sankyo Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: CS-7017, Carboplatin and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSouth Korea
Study dates: Mar 2010to Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC)
No prior systemic therapy for NSCLC
Male or female ≥ 18 years of age
Anticipation of more than 3 months survival
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
Adequate organ and bone marrow function

Who cannot join

Anticipation of need for a major surgical procedure or radiation therapy during the study
Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma)
Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBs)- or hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)- positive and receiving antiretroviral therapy

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Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment
History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
Poorly-controlled blood pressure as judged by the Investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Samsung Medical Center
Seoul, Gangnam-gu, 135-710

Other trials in South Korea

About this study

Official title: Phase 1b Study of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: CS-7017, Carboplatin, Paclitaxel
Keywords: PPAR gamma agonist, Tumor, Cancer, Antineoplastic Agent, Respiratory Tract Neoplasms, Carboplatin, Paclitaxel, Neoplasms
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Neoplasms, Respiratory Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS-7017Drug
Also called CS7017
Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks)
CarboplatinDrug
Also called Paraplatin
Drug: Carboplatin IV, AUC of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
PaclitaxelDrug
Also called Taxol
Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)

Study groups in NCT01199055
Study group	Role	What they receive
CS-7017+Carboplatin/Paclitaxel	Experimental	Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Receives: Drug: CS-7017; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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).
Measured: 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 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
The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
Measured: 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 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
The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
Measured: 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
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
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.
Measured: Baseline to end of Cycle 1, with each treatment cycle being 3 weeks

Secondary outcomes (2)

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)
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.
Measured: Baseline up to Week 18 postdose
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
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.
Measured: Baseline to 30 days after last dose, up to approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jul 2011

First posted10 Sep 2010 (estimated)
Study startMar 2010
Primary completionApr 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199055
Sponsor's protocol ID: CS7017-A-A108
Status last verified: Jun 2020
First submitted: 30 Aug 2010
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b Study of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT01199055
Acronym / sponsor ID: CS7017-A-A108
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: PPAR gamma agonist, Tumor, Cancer, Antineoplastic Agent, Respiratory Tract Neoplasms, Carboplatin, Paclitaxel, Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: ICON Clinical Research
Study start: Mar 2010
Primary completion: Apr 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 10 Sep 2010 (estimated)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CS-7017+Carboplatin/Paclitaxel	Experimental	Drug: CS-7017, Drug: Carboplatin, Drug: PaclitaxelDrug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC)
No prior systemic therapy for NSCLC
Male or female ≥ 18 years of age
Anticipation of more than 3 months survival
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1

Key exclusion criteria (11 listed)

Anticipation of need for a major surgical procedure or radiation therapy during the study
Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma)
Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS-7017Also: CS7017Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks)	Drug	CS-7017+Carboplatin/Paclitaxel
CarboplatinAlso: ParaplatinDrug: Carboplatin IV, AUC of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)	Drug	CS-7017+Carboplatin/Paclitaxel
PaclitaxelAlso: TaxolDrug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)	Drug	CS-7017+Carboplatin/Paclitaxel

Primary outcome

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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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.

2 secondary outcomes

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)
Time frame: Baseline up to Week 18 postdose
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
Time frame: Baseline to 30 days after last dose, up to approximately 1 year

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CS-7017 0.25 mg BID; Initial Portion	3	1
CS-7017 0.50 mg BID; Initial Portion	4	1
CS-7017 0.50 mg BID; Additional Portion	9	5

Primary outcome: 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

Time frame: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	CS-7017 0.25 mg BID; Initial Portion n = 3	CS-7017 0.50 mg BID; Initial Portion n = 4	CS-7017 0.50 mg BID; Additional Portion n = 9
Cycle 1, Week 1: AUCtau	70.66 (54.11)	209.33 (131.40)	203.99 (91.34)
Cycle 1, Week 1: AUClast	49.57 (36.86)	87.23 (85.69)	81.54 (66.01)
Cycle 2, Week 4: AUCtau	132.47 (25.49)	345.56 (156.29)	400.89 (212.22)
Cycle 2, Week 4: AUClast	95.94 (15.84)	240.61 (107.09)	268.00 (134.40)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: 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

Measure	CS-7017 0.25 mg BID; Initial Portion n = 3	CS-7017 0.50 mg BID; Initial Portion n = 4	CS-7017 0.50 mg BID; Additional Portion n = 9
Cycle 1, Week 1: Cmax	8.90 (7.01)	15.98 (16.77)	14.54 (9.75)
Cycle 2, Week 4: Cmax,ss	13.63 (1.77)	33.83 (15.42)	39.58 (18.63)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: 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

Measure	CS-7017 0.25 mg BID; Initial Portion n = 3	CS-7017 0.50 mg BID; Initial Portion n = 3	CS-7017 0.50 mg BID; Additional Portion n = 9
Cycle 1, Week 1: Tmax	3.90 (1.98 to 3.95)	3.00 (2.92 to 6.05)	5.95 (2.00 to 8.10)
Cycle 2, Week 4: Tmax,ss	3.17 (3.02 to 4.08)	3.98 (2.90 to 4.12)	3.88 (1.95 to 6.02)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: 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

Time frame: Baseline to end of Cycle 1, with each treatment cycle being 3 weeks. Count of participants. Unit: Participants

Measure	CS-7017 0.25 mg BID; Initial Portion n = 3	CS-7017 0.50 mg BID; Initial Portion n = 4	CS-7017 0.50 mg BID; Additional Portion n = 9
At least one TEAE	3	4	9
Blood and lymphatic system disorders	3	2	8
Neutropenia	3	2	7
Anaemia	0	0	5
Metabolism and Nutrition Disorders	0	2	6
Decreased appetite	0	1	6
Nervous System Disorders	1	1	4
Neuropathy peripheral	0	1	4

Population analysed: TEAEs were assessed in the Safety Analysis Set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CS-7017 0.25 mg BID; Initial Portion	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
CS-7017 0.50 mg BID; Initial Portion	1 of 4 (25%)	4 of 4 (100%)	1 of 4
CS-7017 0.50 mg BID; Additional Portion	6 of 9 (66.7%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CS-7017, Carboplatin and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Daiichi Sankyo Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.