Trial · NCT01143402
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 | Progression-free Survival (PFS) (Evaluable Randomized Patients) | The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Secondary | Median Overall Survival (Evaluable Randomized Patients) | The time from randomization to death due to any cause, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Other | Objective Disease Progression | assessed up to 5 years | per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression |
| Other | Overall Survival | The time from randomization to death due to any cause, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Other | Response Rate (Complete and Partial Response) | Up to 5 years | Calculated along with a 95% confidence interval. |
| Other | Toxicity According to the National Cancer Institute Common Toxicity Criteria | Up to 5 years | Toxicity will be reported by type, frequency, and severity. Please see adverse events. |
| Other | PFS (Group 3) | 4 months | Evaluated using a Simon mini-max design. Curves will be generated using Kaplan-Meier methodology. |
| Other | Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage | Up to 5 years | Changes will be assessed by a Wilcoxon test |
| Other | Change in Ki67 | Baseline up to 4 months | Correlated with disease status using Fishers exact test. |
| Other | Change in p-AKT | Baseline up to 4 months | Correlated with disease status using Fishers exact test. |
| Other | Change in p-ERK | Baseline up to 4 months | Decrease in p-ERK will be correlated with disease status using Fishers exact test. |
| Other | Change in PTEN | Baseline up to 4 months | Correlated with disease status using Fishers exact test. |
| Other | Changes in Maximum Standardized Uptake Value on FLT-PET Scans | Baseline up to 60 minutes post injection | A paired student's t-test will be performed. Analysis of variance will also be performed to obtain the significance of FLT-PET uptake on each lesion between patients. |
| Other | FACT-M Total Score | Up to 5 years | Summarized using descriptive statistics for each assessment time and by treatment group. The scores will be compared between treatment groups using a mixed effect model for repeated measures analysis method. Treatment difference will be estimated from the model for each assessment time. |
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
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GET https://conductscience.org/api/trials/v1/NCT01143402/registered