Back to resultsClinical 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)
Primary Purpose
Small Cell Lung Carcinoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Roniciclib (BAY1000394)
Etoposide
Cisplatin
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Cyclin dependent kinases, Drug therapy, combination, Small cell lung carcinoma, Etoposide, Cisplatin, Carboplatin
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm 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.
Outcomes
Primary Outcome Measures
Safety variables will be summarized using descriptive statistics based on adverse events collection
tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy
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
Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
Secondary Outcome Measures
Disease control rate (DCR)
number of patients with complete response, partial response or stable disease according to RECIST
Overall survival (OS)
time (days) from date of first treatment to death due to any cause.
Time to progression (TTP)
time (days) from date of first treatment to first observed radiological disease progression
Progression-free survival (PFS)
time (days) from date of first treatment to first observed radiological disease progression or death
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
Stable disease (SD)
time (days) from date of first treatment to first observed radiological disease progression or death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01573338
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Study Start Date
February 25, 2013 (Actual)
Primary Completion Date
March 25, 2016 (Actual)
Study Completion Date
June 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma
Keywords
Cyclin dependent kinases, Drug therapy, combination, Small cell lung carcinoma, Etoposide, Cisplatin, Carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Roniciclib (BAY1000394)
Intervention Description
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
Intervention Name(s)
Etoposide
Intervention Description
100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame
up to 3 years
Title
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
Title
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
Title
Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
Time Frame
Cycle 1, Day 8 and Cycle 2, Day 1
Title
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
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
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
Title
Overall survival (OS)
Description
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
Title
Time to progression (TTP)
Description
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
Title
Progression-free survival (PFS)
Description
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
Title
Duration of response (DOR)
Description
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
Title
Stable disease (SD)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Learn more about this trial
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)
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