Trial · NCT02444546
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 | MTD, based on the incidence of dose-limiting toxicity (DLT) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 | Up to 84 days | MTD is the highest safely tolerated dose level where 1 of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. |
| Secondary | Adverse event profile | Up to 5 years | The number and severity of adverse events (overall, by dose level, by treatment received) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion. |
| Secondary | Objective responses | Up to 5 years | Objective responses will be summarized by descriptive summary statistics delineating complete and partial responses and stable and progressive disease. |
| Secondary | Overall survival | Up to 5 years | Will be summarized descriptively. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and relevant confidence intervals. |
| Secondary | Time to progression | Will be summarized descriptively. | Up to 5 years |
| Secondary | Time to treatment failure | Up to 5 years | Will be summarized descriptively. Time to treatment failure is defined as the time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient. |
| Secondary | Time until any treatment-related toxicity | Up to 5 years | Will be summarized descriptively. |
| Secondary | Time until treatment-related grade 3+ toxicity | Up to 5 years | Will be summarized descriptively. |
| Secondary | Toxicity profile, assessed by CTCAE v4.0 | Up to 5 years | Toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Overall toxicity incidence and toxicity profiles by dose level, patient, and treatment will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. |
| Other | Immunologic parameters | Up to 5 years | For each of the immunologic parameters, a time series plot will be constructed. A grid reflecting the percent change from pre-treatment levels will be constructed. This grid will be analyzed to determine if the changes seen in each immunologic parameter differ between patients who response and those which do not respond. |
| Other | Reovirus immune status | Up to 5 years | The reovirus immune status will be correlated with objective response to analyze if the status is predictive of sargramostim plus wild-type reovirus therapy. |
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/NCT02444546/registered