Trial record 1 of 1 for:    NCT01573338
Previous Study | Return to List | Next Study

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
  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.


Condition Intervention Phase
Small Cell Lung Carcinoma
Drug: Roniciclib (BAY 1000394)
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 42
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573338

Locations
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
Buffalo, New York, United States, 14263-0001
United States, Ohio
Cleveland, Ohio, United States, 44195
France
Caen Cedex, France, 14033
Lyon Cedex, France, 69008
Marseille, France, 13005
Villejuif Cedex, France, 94805
Korea, Republic of
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01573338     History of Changes
Other Study ID Numbers: 14858, 2011-004155-39
Study First Received: April 5, 2012
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
France: National Agency for the Safety of Medicines and Health Products

Keywords provided by Bayer:
Cyclin dependent kinases
Drug therapy, combination
Small cell lung carcinoma
Etoposide
Cisplatin
Carboplatin

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014