Trial · NCT01573338
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, Phase 1, Phase 2, Terminated, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT01573338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01573338
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT01573338
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Roniciclib (BAY1000394), Etoposide, Cisplatin, Carboplatin
- First posted
- 2012-04-09
- Last updated
- 2021-04-08
- Other registries' IDs
- eudract:2011-004155-39
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety variables will be summarized using descriptive statistics based on adverse events collection | up to 3 years | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394 | Cycle 1, Day 8 and Cycle 2, Day 1 | |
| Primary | 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 | Disease control rate (DCR) | 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 |
| Secondary | Overall survival (OS) | 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. |
| Secondary | Time to progression (TTP) | 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 |
| Secondary | Progression-free survival (PFS) | 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 |
| Secondary | Duration of response (DOR) | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01573338
GET https://conductscience.org/api/trials/v1/NCT01573338/registered