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

NCT00806286 | Completed Phase 2 Results

• 1 other identifier: CS7017-A-U202
• Study Type: interventional
• Target: 111
• Locations: 4 countries
• Sites: 28

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

  Baseline to date of death, up to approximately 2 years postdose

• 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

  Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose

• 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

Study Arms (2)

CS-7017 with Paclitaxel and Carboplatin

EXPERIMENTAL

Drug: CS7017 tablets; Drug: Paclitaxel; Drug: Carboplatin

Paclitaxel and Carboplatin

PLACEBO COMPARATOR

Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo Tablets

Interventions

CS7017 tablets DRUG

CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months

CS-7017 with Paclitaxel and Carboplatin

Paclitaxel DRUG

Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks

CS-7017 with Paclitaxel and Carboplatin; Paclitaxel and Carboplatin

Carboplatin DRUG

IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks

CS-7017 with Paclitaxel and Carboplatin; Paclitaxel and Carboplatin

Placebo Tablets DRUG

Placebo tablets matching CS-7017 tablets

Paclitaxel and Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (28)

University Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Georgetown Univ. Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Southern Illinois Hematology/Oncology

Centralia, Illinois, 45042, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Michiana Hematology-Oncology

South Bend, Indiana, 46601, United States

Location

Harbor View Cancer Center

Baltimore, Maryland, 21225, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 62801, United States

Location

Penn State Milton Hershey Cancer Center

Hershey, Pennsylvania, 17033, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Pentagon Research

Aundh, Maharashtra, 411007, India

Location

Shatabdi Super Specialty Hospital

Nashik, Mumbai Naka, 422005, India

Location

Hemato-Oncology Clinic, Vedanta

Gujarat, Navrangpura, Ahmedabad, 380009, India

Location

Meenakshi Mission Hospital

Madurai, Tamil Nadu, 625 107, India

Location

Orchid Nursing Home

Kolkata, West Bengal, 700054, India

Location

Apollo Specialty Hospital

Chennai, 600035, India

Location

Ruby Hall Clinic

Pune, 411 001, India

Location

Noble Hospital

Pune, 411 013, India

Location

Oddzial Chemioterapii ZOZ MSWiA

Olsztyn, 10-228, Poland

Location

Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

Poznan, 60-569, Poland

Location

Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego

Szczecin, 70-891, Poland

Location

Oncomed SRL

Timișoara, Judet Timis, 300239, Romania

Location

Spitalul Municipal Ploiesti

Ploieşti, Prahova, Romania

Location

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu

Bucharest, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, 400015, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Romania

Location

Centrul de Oncologie Medicala

Iași, Romania

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

efatutazone; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 13, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

US (10); PL (3); RO (6); IN (9)