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Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Carcinoma

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Trial Information

Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer


Inclusion Criteria:



- Male or female subjects aged >/=18 years

- Histologically or cytologically confirmed, extensive disease SCLC

- At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic
resonance imaging (MRI) according to RECIST 1.1. Subjects with non-measurable disease
according to RECIST 1.1 can be included in the Phase Ib part of the study

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

- Life expectancy of at least 12 weeks

- Serum sodium >/=130 mmol/L

Exclusion Criteria:

- Prior systemic anticancer therapy

- Prior radiotherapy (local palliative radiotherapy is permitted)

- History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina
(anginal symptoms at rest), any episodes of angina or history of myocardial
infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or
digoxin are permitted), previous venous or arterial thrombotic events, pulmonary
embolism

- Moderate or severe hepatic impairment, ie Child-Pugh class B or C

- Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety variables will be summarized using descriptive statistics based on adverse events collection

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

14858

NCT ID:

NCT01573338

Start Date:

February 2013

Completion Date:

December 2015

Related Keywords:

  • Small Cell Lung Carcinoma
  • Cyclin dependent kinases
  • Drug therapy, combination
  • Small cell lung carcinoma
  • Etoposide
  • Cisplatin
  • Carboplatin
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195