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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: CS-7017 (Drug); Carboplatin (Drug); Paclitaxel (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Daiichi Sankyo Co., Ltd.

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

treatment emergent adverse events

plasma concentration of CS-7017

treatment-emergent serious adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Samsung Medical Center, Seoul, Gangnam-gu 135-710, Korea, Republic of
Additional Information

Starting date: March 2010
Last updated: July 11, 2011

Page last updated: August 23, 2015

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