Comparison · NCT01038778-4e09da82
Dose Level 1 vs Dose Level 2: Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Dose Level 1 vs Dose Level 2: Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I. Trial comparisons, record NCT01038778-4e09da82. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01038778-4e09da82
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.324 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dose Level 1 | Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV) | 0 | 3 | OG000 |
| Group 2 | Dose Level 2 | Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV) | 0 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I
- Description
Number of dose-limiting toxicities of entinostat when combined with aldesleukin within the Phase I MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)
- Time frame
- 84 days
- Population
- All treated and eligible Phase 1 patients
Source ClinicalTrials.gov
Trial
- Title
- Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer
- NCT number
- NCT01038778
- Phases
- PHASE1, PHASE2
- Conditions
- Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
- Interventions
- Aldesleukin, Computed Tomography, Entinostat, Fludeoxyglucose F-18, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01038778?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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