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Trial record 1 of 1 for:    NCT01573338
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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 (Smal Cell Lung Cancer)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01573338
First received: April 5, 2012
Last updated: September 25, 2014
Last verified: September 2014

April 5, 2012
September 25, 2014
February 2013
December 2015   (final data collection date for primary outcome measure)
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as 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 [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394 [ Time Frame: Cycle 1, Day 8 and Cycle 2, Day 1 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01573338 on ClinicalTrials.gov Archive Site
  • Disease control rate (DCR) [ Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks ] [ Designated as safety issue: No ]
    number of patients with complete response, partial response or stable disease according to RECIST
  • Overall survival (OS) [ Time Frame: From start of treatment of the first subject until 3 years later ] [ Designated as safety issue: No ]
    time (days) from date of first treatment to death due to any cause.
  • Time to progression (TTP) [ Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks ] [ Designated as safety issue: No ]
    time (days) from date of first treatment to first observed radiological disease progression
  • Progression-free survival (PFS) [ Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks ] [ Designated as safety issue: No ]
    time (days) from date of first treatment to first observed radiological disease progression or death
  • Duration of response (DOR) [ Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks ] [ Designated as safety issue: No ]
    time (days) from date of first radiological response to the date that progressive disease is first radiologically documented or death occurs
Same as current
Not Provided
Not Provided
 
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 (Smal Cell Lung Cancer)
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

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
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Carcinoma
  • Drug: Roniciclib (BAY 1000394)
    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.
  • Drug: Etoposide
    100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
  • Drug: Cisplatin
    75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
  • Drug: Carboplatin
    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.
Experimental: Arm 1
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.
Interventions:
  • Drug: Roniciclib (BAY 1000394)
  • Drug: Etoposide
  • Drug: Cisplatin
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Korea, Republic of
 
NCT01573338
14858, 2011-004155-39
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP