stop_circleTerminated/Withdrawn

Small Cell Lung Carcinoma

Bayer Identifier:

14858

ClinicalTrials.gov Identifier:

NCT01573338

EudraCT Number:

2011-004155-39

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
43
Trial Dates
February 2013 - June 2016
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
St. Louis, 63110, United States
Completed
Seoul, 03080, Korea, Republic Of
Completed
Seoul, 03722, Korea, Republic Of
Completed
Cleveland, 44195, United States
Completed
Buffalo, 14263-0001, United States
Completed
VILLEJUIF CEDEX, 94805, France
Completed
MARSEILLE, 13005, France
Withdrawn
LYON CEDEX, 69008, France
Completed
CAEN CEDEX, 14033, France

Primary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
    date_rangeTime Frame:
    Cycle 1, Day 8 and Cycle 2, Day 1
    enhanced_encryption
    Safety Issue:
    Yes
  • Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
    date_rangeTime Frame:
    Cycle 1, Day 8 and Cycle 2, Day 1
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Disease control rate (DCR)
    number of patients with complete response, partial response or stable disease according to RECIST
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later, assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    time (days) from date of first treatment to death due to any cause.
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP)
    time (days) from date of first treatment to first observed radiological disease progression
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later, assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS)
    time (days) from date of first treatment to first observed radiological disease progression or death
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later, assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later, assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Stable disease (SD)
    time (days) from date of first treatment to first observed radiological disease progression or death
    date_rangeTime Frame:
    From start of treatment of the first subject until 3 years later, assessed every 6 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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