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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
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.
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Buffalo, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Caen, France
Unnamed facility
Marseille, France
Unnamed facility
Villejuif, France
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: up to 3 years
tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy
Time frame: up to 3 years
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
Time frame: up to 3 years
Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
Time frame: Cycle 1, Day 8 and Cycle 2, Day 1
Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
Time frame: Cycle 1, Day 8 and Cycle 2, Day 1
Disease control rate (DCR)
number of patients with complete response, partial response or stable disease according to RECIST
Time frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Overall survival (OS)
time (days) from date of first treatment to death due to any cause.
Time frame: From start of treatment of the first subject until 3 years later
Time to progression (TTP)
time (days) from date of first treatment to first observed radiological disease progression
Time frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Progression-free survival (PFS)
time (days) from date of first treatment to first observed radiological disease progression or death
Time frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Duration of response (DOR)
time (days) from date of first radiological response to the date that progressive disease is first radiologically documented or death occurs
Time frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Stable disease (SD)
time (days) from date of first treatment to first observed radiological disease progression or death
Time frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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