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

This study has been completed.
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01199055
First received: August 30, 2010
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: CS-7017
Drug: Carboplatin
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • treatment emergent adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Number of subjects reporting Treatment Emergent Adverse Events (TEAEs) as a measure of safety and tolerability.

  • plasma concentration of CS-7017 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    To determine the plasma concentration of CS-7017 at Days 1, 8, 15, 22, 43, and 64 after study drug administration.

  • treatment-emergent serious adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Number of subjects reporting treatment-emergent serious adverse events (SAEs) as a measure of safety and tolerability.


Estimated Enrollment: 21
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-7017+Carboplatin/Paclitaxel
Drug: CS-7017 from 0.25 mg bid to 0.50 mg bid for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, AUC of 6, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Drug: CS-7017
Drug: CS-7017 from 0.25 mg bid to 0.50 mg bid for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: CS7017
Drug: Carboplatin
Drug: Carboplatin IV, AUC of 6, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: Paraplatin
Drug: Paclitaxel
Drug: Paclitaxel IV, 200mg/m2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: Taxol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199055

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
ICON Clinical Research
  More Information

No publications provided

Responsible Party: Toshio Asami / Assistant Manager, Daiichi Sankyo Tokyo
ClinicalTrials.gov Identifier: NCT01199055     History of Changes
Other Study ID Numbers: CS7017-A-A108
Study First Received: August 30, 2010
Last Updated: July 11, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
PPAR gamma agonist
Tumor
Cancer
Antineoplastic Agent
Respiratory Tract Neoplasms
Carboplatin
Paclitaxel
Neoplasms

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014