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NCT01573338 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01573338: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT01573338 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573338, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Roniciclib (BAY1000394)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-02-25 |
| Est. Completion | 2016-06-23 |
| Phase | Phase 1 |
Why NCT01573338 stopped before completion
NCT01573338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01573338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01573338 about?
NCT01573338 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT01573338?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2013-02-25. Estimated completion is 2016-06-23.
What interventions are being tested in trial NCT01573338?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Roniciclib (BAY1000394) (DRUG).
Who is sponsoring clinical trial NCT01573338?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01573338's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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