Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb1 enrolled

Overview

The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

KOS-1584DRUG

25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV. * Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC. * Good performance status. Exclusion Criteria: * Prior treatment with an epothilone. * Known central nervous system (CNS) metastases. * Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.

Locations (1)

Consultants In Blood Disorders & Cancer

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Objective response rate of KOS-1584

Time frame: up to one year

Secondary Outcomes

Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.

Time frame: up to 2 years

Data from ClinicalTrials.gov

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