Trial · NCT01175980
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response According to RECIST 1.1 Criteria | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Objective (Best) response according to RECIST 1.1 criteria. |
| Secondary | Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity. |
| Secondary | Time to Recurrence (TTR) | From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory. |
| Secondary | Response Duration (RD) | From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months | Median point estimate and full range will be documented, since only two patients achieved a response. |
| Secondary | Progression-free Survival (PFS) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months | Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate. |
| Secondary | Overall Survival (OS) | From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months | Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display. (One year survival rate will be given since OS median was not reached due to too few events) |
| Other | Metabolic Response by PET/CT Scan | Up to 56 days | Will assess the association between a metabolic response by PET/CT after one course of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria. Will also assess the association between a metabolic response by PET/CT after the first and second chemotherapy courses and PFS. |
| Other | Number of Patients With Flow Sort Diploid Populations of Tumor Cells From FFPE Tissue Blocks | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort diploid populations of tumor cells from FFPE tissue blocks reported as a count of participants. |
| Other | Number of Patients With Flow Sort Aneuploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort aneuploid populations of tumor cells from FFPE tissue. Reported as descriptive results. |
| Other | Number of Patients With Flow Sort Tetraploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort tetraploid populations of tumor cells from FFPE tissue. Reported as descriptive results. |
| Other | Unique Probes on the Oligonucleotide CGH Array as a Measure of the Genomic Profile of Each Cell Population. | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Genomic profile of each cell population using oligonucleotide CGH arrays. Reported as unique probes on the CGH array. |
| Other | The Number of Genes Sequenced in the WES Assay as a Measure of the Whole Exome Profile of the Sorted Tumor Population and Matching Germ Line Sample | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Reported as descriptive results. The combined CGH array and exome data will be mined to identify genes and pathways that are targeted by select somatic events in each of the patient subsets. |
| Other | Stable Disease Duration (SDD) | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | SDD will be reported as descriptive results as a median point estimate and a 90% confidence interval (CI) estimate. |
| Other | Expression Level of HR23B | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Exact logistic modeling investigation would yield a point and 90% CI estimate of the odds ratio for response. |
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.
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GET https://conductscience.org/api/trials/v1/NCT01175980/registered