stop_circleTerminated/Withdrawn
Small Cell Lung Carcinoma
Bayer Identifier:
14858
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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)
Trial 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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
43Trial Dates
February 2013 - June 2016Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
Roniciclib (BAY1000394)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | St. Louis, 63110, United States | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | Cleveland, 44195, United States | |
Completed | Buffalo, 14263-0001, United States | |
Completed | VILLEJUIF CEDEX, 94805, France | |
Completed | MARSEILLE, 13005, France | |
Withdrawn | LYON CEDEX, 69008, France | |
Completed | CAEN CEDEX, 14033, France |
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:up to 3 yearsenhanced_encryptionYesSafety Issue:
- tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapydate_rangeTime Frame:up to 3 yearsenhanced_encryptionYesSafety Issue:
- 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 protocoldate_rangeTime Frame:up to 3 yearsenhanced_encryptionYesSafety Issue:
- Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394date_rangeTime Frame:Cycle 1, Day 8 and Cycle 2, Day 1enhanced_encryptionYesSafety Issue:
- Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394date_rangeTime Frame:Cycle 1, Day 8 and Cycle 2, Day 1enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Disease control rate (DCR)number of patients with complete response, partial response or stable disease according to RECISTdate_rangeTime Frame:From start of treatment of the first subject until 3 years later, assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Overall survival (OS)time (days) from date of first treatment to death due to any cause.date_rangeTime Frame:From start of treatment of the first subject until 3 years laterenhanced_encryptionNoSafety Issue:
- Time to progression (TTP)time (days) from date of first treatment to first observed radiological disease progressiondate_rangeTime Frame:From start of treatment of the first subject until 3 years later, assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Progression-free survival (PFS)time (days) from date of first treatment to first observed radiological disease progression or deathdate_rangeTime Frame:From start of treatment of the first subject until 3 years later, assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Duration of response (DOR)time (days) from date of first radiological response to the date that progressive disease is first radiologically documented or death occursdate_rangeTime Frame:From start of treatment of the first subject until 3 years later, assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Stable disease (SD)time (days) from date of first treatment to first observed radiological disease progression or deathdate_rangeTime Frame:From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1