Clinical trial NCT01573338: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Carcinoma
Keywords: Cyclin dependent kinases
Drug therapy, combination
Small cell lung carcinoma
Etoposide
Cisplatin
Carboplatin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: up to 3 years
measure: tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy
timeFrame: up to 3 years
measure: Maximum Tolerated Dose (MTD) - measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where non or 1 of 6 subjects experience a dose limiting toxicity as defined in the protocol
timeFrame: up to 3 years
measure: Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
timeFrame: Cycle 1, Day 8 and Cycle 2, Day 1
measure: Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
timeFrame: Cycle 1, Day 8 and Cycle 2, Day 1
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
measure: Overall survival (OS)
timeFrame: From start of treatment of the first subject until 3 years later
measure: Time to progression (TTP)
timeFrame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
measure: Progression-free survival (PFS)
timeFrame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
measure: Duration of response (DOR)
timeFrame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
measure: Stable disease (SD)
timeFrame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Caen Cedex
country: France
city: Marseille
country: France
city: Villejuif Cedex
country: France
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: