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Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

Primary Purpose

Metastatic Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CS7017 tablets
Paclitaxel
Carboplatin
Placebo Tablets
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
  • Age greater than or equal to 18 years
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Any prior systemic therapy for NSCLC
  • Major surgical procedure or other investigational agents within 4 weeks before study enrollment
  • Need for concomitant use of other thiazolidinediones during the study
  • History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
  • Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis

Sites / Locations

  • University Colorado Cancer Center
  • Georgetown Univ. Medical Center
  • Southern Illinois Hematology/Oncology
  • Rush University Medical Center
  • Michiana Hematology-Oncology
  • Harbor View Cancer Center
  • Massachusetts General Hospital
  • Signal Point Clinical Research Center
  • Penn State Milton Hershey Cancer Center
  • Eastern Virginia Medical School
  • Kidwai Memorial Institute of Oncology
  • Pentagon Research
  • Shatabdi Super Specialty Hospital
  • Hemato-Oncology Clinic, Vedanta
  • Meenakshi Mission Hospital
  • Orchid Nursing Home
  • Apollo Specialty Hospital
  • Ruby Hall Clinic
  • Noble Hospital
  • Oddzial Chemioterapii ZOZ MSWiA
  • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
  • Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego
  • Oncomed SRL
  • Spitalul Municipal Ploiesti
  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
  • Institutul Oncologic Prof. Dr. Ion Chiricuta
  • Institutul Oncologic Prof. Dr. Ion Chiricuta
  • Centrul de Oncologie Medicala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CS-7017 with Paclitaxel and Carboplatin

Paclitaxel and Carboplatin

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started.
Percentage of Participants With Progression-Free Survival Based on Radiologic and Clinical Assessments and Death After Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. Disease progression was determined in accordance with the RECIST version 1.0 criteria.

Secondary Outcome Measures

Summary of Kaplan-Meier Analysis of Overall Survival Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Overall survival (OS) is defined as the time from randomization to the date of death resulting from any cause.
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
As per Response Evaluation Criteria for Solid Tumors v1.0, the best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR.
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer

Full Information

First Posted
December 9, 2008
Last Updated
May 1, 2020
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00806286
Brief Title
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Official Title
Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-7017 with Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Title
Paclitaxel and Carboplatin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CS7017 tablets
Intervention Description
CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Intervention Description
Placebo tablets matching CS-7017 tablets
Primary Outcome Measure Information:
Title
Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Description
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started.
Time Frame
18 weeks postdose
Title
Percentage of Participants With Progression-Free Survival Based on Radiologic and Clinical Assessments and Death After Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Description
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. Disease progression was determined in accordance with the RECIST version 1.0 criteria.
Time Frame
18 weeks postdose
Secondary Outcome Measure Information:
Title
Summary of Kaplan-Meier Analysis of Overall Survival Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Description
Overall survival (OS) is defined as the time from randomization to the date of death resulting from any cause.
Time Frame
Baseline to date of death, up to approximately 2 years postdose
Title
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Description
As per Response Evaluation Criteria for Solid Tumors v1.0, the best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR.
Time Frame
Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose
Title
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer
Time Frame
Baseline up to approximately 2 years postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor Age greater than or equal to 18 years Adequate organ and bone marrow function Exclusion Criteria: Any prior systemic therapy for NSCLC Major surgical procedure or other investigational agents within 4 weeks before study enrollment Need for concomitant use of other thiazolidinediones during the study History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction; Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown Univ. Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Southern Illinois Hematology/Oncology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
45042
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Michiana Hematology-Oncology
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Harbor View Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
62801
Country
United States
Facility Name
Penn State Milton Hershey Cancer Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
Facility Name
Pentagon Research
City
Aundh
State/Province
Maharashtra
ZIP/Postal Code
411007
Country
India
Facility Name
Shatabdi Super Specialty Hospital
City
Nashik
State/Province
Mumbai Naka
ZIP/Postal Code
422005
Country
India
Facility Name
Hemato-Oncology Clinic, Vedanta
City
Gujarat
State/Province
Navrangpura, Ahmedabad
ZIP/Postal Code
380009
Country
India
Facility Name
Meenakshi Mission Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 107
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Apollo Specialty Hospital
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
Noble Hospital
City
Pune
ZIP/Postal Code
411 013
Country
India
Facility Name
Oddzial Chemioterapii ZOZ MSWiA
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Oncomed SRL
City
Timisoara
State/Province
Judet Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
Spitalul Municipal Ploiesti
City
Ploiesti
State/Province
Prahova
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
City
Bucuresti
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuta
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuta
City
Cluj-Napoca
Country
Romania
Facility Name
Centrul de Oncologie Medicala
City
Iasi
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

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