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)

April 6, 2021 updated by: Bayer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen Cedex, France, 14033
      • Marseille, France, 13005
      • Villejuif Cedex, France, 94805
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 03722
  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New York
      • Buffalo, New York, United States, 14263-0001
    • Ohio
      • Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 (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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: up to 3 years
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
Time Frame: up to 3 years
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
Time Frame: up to 3 years
up to 3 years
Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
Time Frame: Cycle 1, Day 8 and Cycle 2, Day 1
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
Time Frame: Cycle 1, Day 8 and Cycle 2, Day 1
Cycle 1, Day 8 and Cycle 2, Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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
Overall survival (OS)
Time Frame: From start of treatment of the first subject until 3 years later
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
Time to progression (TTP)
Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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
Progression-free survival (PFS)
Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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
Duration of response (DOR)
Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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
Stable disease (SD)
Time Frame: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2013

Primary Completion (ACTUAL)

March 25, 2016

Study Completion (ACTUAL)

June 23, 2016

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (ESTIMATE)

April 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14858
  • 2011-004155-39 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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