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

Metastatic Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806286
• Other study ID #: CS7017-A-U202
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer

Intervention

Drug:
• CS7017 tablets
CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months
• Paclitaxel
Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks
• Carboplatin
IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
• Placebo Tablets
Placebo tablets matching CS-7017 tablets

Locations

Country	Name	City	State
India	Pentagon Research	Aundh	Maharashtra
India	Kidwai Memorial Institute of Oncology	Bangalore	Karnataka
India	Apollo Specialty Hospital	Chennai
India	Hemato-Oncology Clinic, Vedanta	Gujarat	Navrangpura, Ahmedabad
India	Orchid Nursing Home	Kolkata	West Bengal
India	Meenakshi Mission Hospital	Madurai	Tamil Nadu
India	Shatabdi Super Specialty Hospital	Nashik	Mumbai Naka
India	Noble Hospital	Pune
India	Ruby Hall Clinic	Pune
Poland	Oddzial Chemioterapii ZOZ MSWiA	Olsztyn
Poland	Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii	Poznan
Poland	Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego	Szczecin
Romania	Institutul Oncologic Prof. Dr. Alexandru Trestioreanu	Bucuresti
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta	Cluj-Napoca
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta	Cluj-Napoca
Romania	Centrul de Oncologie Medicala	Iasi
Romania	Spitalul Municipal Ploiesti	Ploiesti	Prahova
Romania	Oncomed SRL	Timisoara	Judet Timis
United States	University Colorado Cancer Center	Aurora	Colorado
United States	Harbor View Cancer Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southern Illinois Hematology/Oncology	Centralia	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Penn State Milton Hershey Cancer Center	Hershey	Pennsylvania
United States	Signal Point Clinical Research Center	Middletown	Ohio
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Michiana Hematology-Oncology	South Bend	Indiana
United States	Georgetown Univ. Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  India,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 weeks postdose
Primary	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.	18 weeks postdose
Secondary	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.	Baseline to date of death, up to approximately 2 years postdose
Secondary	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.	Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose
Secondary	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		Baseline up to approximately 2 years postdose