Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004155-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roniciclib (BAY1000394) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events collection | 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 | 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 | up to 3 years | |
| Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394 | 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 | Cycle 1, Day 8 and Cycle 2, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | number of patients with complete response, partial response or stable disease according to RECIST | From start of treatment of the first subject until 3 years later, assessed every 6 weeks |
| Overall survival (OS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Louis | Missouri | 63110 | United States | |||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Etoposide | Drug | 100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle. |
|
| Cisplatin | Drug | 75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete. |
|
| Carboplatin | 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. |
|
time (days) from date of first treatment to death due to any cause.
| 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 | 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 | 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 | 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 | From start of treatment of the first subject until 3 years later, assessed every 6 weeks |
| Buffalo |
| New York |
| 14263-0001 |
| United States |
| Cleveland | Ohio | 44195 | United States |
| Caen | 14033 | France |
| Marseille | 13005 | France |
| Villejuif | 94805 | France |
| Seoul | 03080 | South Korea |
| Seoul | 03722 | South Korea |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578610 | roniciclib |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
Not provided
Not provided