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)

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01573338
• Other study ID #: 14858
• Secondary ID: 2011-004155-39
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 25, 2013
• Est. completion date: June 23, 2016

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: June 23, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Roniciclib (BAY1000394)
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.
• Etoposide
100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
• Cisplatin
75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  France,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables will be summarized using descriptive statistics based on adverse events collection		up to 3 years
Primary	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
Primary	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
Primary	Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394		Cycle 1, Day 8 and Cycle 2, Day 1
Primary	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
Secondary	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
Secondary	Overall survival (OS)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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