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 currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01573338
First received: April 5, 2012
Last updated: May 8, 2013
Last verified: May 2013
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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: BAY1000394 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
| Estimated Enrollment: | 60 |
| 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: 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.
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573338
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22397 |
Locations
| United States, Missouri | |
| Not yet recruiting | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Not yet recruiting | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Ohio | |
| Not yet recruiting | |
| Cleveland, Ohio, United States, 44195 | |
| France | |
| Not yet recruiting | |
| Caen Cedex, France, 14033 | |
| Not yet recruiting | |
| Lyon Cedex, France, 69008 | |
| Not yet recruiting | |
| Marseille, France, 13005 | |
| Not yet recruiting | |
| Villejuif Cedex, France, 94805 | |
| Korea, Republic of | |
| Recruiting | |
| Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744 | |
| Not yet recruiting | |
| 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: | Head of Clinical Sciences, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01573338 History of Changes |
| Other Study ID Numbers: | 14858, 2011-004155-39 |
| Study First Received: | April 5, 2012 |
| Last Updated: | May 8, 2013 |
| 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 Etoposide Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013