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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-25

Study Completion Date

2016-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

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.

Group Type EXPERIMENTAL

Roniciclib (BAY1000394)

Intervention Type DRUG

oral administration twice daily in a 3 days on/ 4 days off schedule. Starting dose will be 2.5 mg bid and dose will be escalated or de-escalated depending on dose limiting toxicity.

Etoposide

Intervention Type DRUG

100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.

Cisplatin

Intervention Type DRUG

75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered IV on Day 1 of each 21 day cycle. The dose of carboplatin will be determined for each cycle using the Calvert's formula, to yield an AUC of 5 (mg/mL) • min.

Interventions

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Roniciclib (BAY1000394)

oral administration twice daily in a 3 days on/ 4 days off schedule. Starting dose will be 2.5 mg bid and dose will be escalated or de-escalated depending on dose limiting toxicity.

Intervention Type DRUG

Etoposide

100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.

Intervention Type DRUG

Cisplatin

75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.

Intervention Type DRUG

Carboplatin

Carboplatin will be administered IV on Day 1 of each 21 day cycle. The dose of carboplatin will be determined for each cycle using the Calvert's formula, to yield an AUC of 5 (mg/mL) • min.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No