Trial · NCT01573338
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | Stable disease (SD) | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01573338/registered