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)

NCT01573338 | Terminated Phase 1

• 2 other identifiers: 148582011-004155-39
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 8

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.

Conditions

Small Cell Lung Carcinoma

Keywords

Cyclin dependent kinases; Drug therapy, combination; Small cell lung carcinoma; Etoposide; Cisplatin; Carboplatin

Outcome Measures

Primary Outcomes (5)

• Safety variables will be summarized using descriptive statistics based on adverse events collection

  up to 3 years

• 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

• 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

• Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394

  Cycle 1, Day 8 and Cycle 2, Day 1

• 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 Outcomes (6)

• Disease control rate (DCR)

  From start of treatment of the first subject until 3 years later, assessed every 6 weeks

• Overall survival (OS)

  From start of treatment of the first subject until 3 years later

• Time to progression (TTP)

  From start of treatment of the first subject until 3 years later, assessed every 6 weeks

• Progression-free survival (PFS)

  From start of treatment of the first subject until 3 years later, assessed every 6 weeks

• Duration of response (DOR)

  From start of treatment of the first subject until 3 years later, assessed every 6 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

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 (BAY1000394); Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

Interventions

Roniciclib (BAY1000394) DRUG

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.

Arm 1

Etoposide DRUG

100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.

Arm 1

Cisplatin DRUG

75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.

Arm 1

Carboplatin DRUG

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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Buffalo, New York, 14263-0001, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Caen, 14033, France

Location

Unknown Facility

Marseille, 13005, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Seoul, 03080, South Korea

Location

Unknown Facility

Seoul, 03722, South Korea

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

roniciclib; Etoposide; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: February 25, 2013
• Primary Completion: March 25, 2016
• Study Completion: June 23, 2016
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (3); FR (3); KR (2)