Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 When Given Together With Chemotherapy and the Effectiveness of This Combination Treatment in Shrinking a Specific Type of Lung Tumors (Small Cell Lung Cancer)

Bayer

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Carboplatin; Drug: Roniciclib (BAY1000394); Drug: Etoposide; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573338

2011-004155-39 (EudraCT Number)

14858

Details and patient eligibility

About

This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Arm 1

Experimental group

Description:

BAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Roniciclib (BAY1000394)

Drug: Etoposide