Comparison · NCT01434602-3875badc
Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily vs Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily: Number of Participants With a Dose-limiting Toxicity (DLT)
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. Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily vs Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily: Number of Participants With a Dose-limiting Toxicity (DLT). Trial comparisons, record NCT01434602-3875badc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01434602-3875badc
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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 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk in group 2 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk difference, group 1 minus group 2 | 0.333 | -0.172 | 0.674 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.423 | 21.3 | log | |
| Odds ratio, group 1 over group 2 | 5 | 0.344 | 72.8 | log | |
Number needed to treat, for one more participant with the outcome on Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily than on Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily | 3 | from the risk difference interval | the interval includes no difference |
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 | Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily | Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. | 3 | 6 | OG000 |
| Group 2 | Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily | Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21. | 1 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With a Dose-limiting Toxicity (DLT)
- Description
A DLT is any grade 3 thrombocytopenia, grade 4 anemia, grade 4 neutropenia, or febrile neutropenia of any grade. Any non-hematologic grade 3 or grade 4 toxicity, excluding alopecia and/or hand/foot reaction. Failure to recover from toxicities (to grade 1 or less) to be eligible for re-treatment with sorafenib and everolimus within 14 days of the last dose of sorafenib and everolimus.
- Time frame
- First 28 days of treatment only (cycle 1)
- Population
- Phase II is not applicable for this outcome measure. 6/7 subjects were evaluable in Dose Level-1 because one participant was excluded for under-dosing.
Source ClinicalTrials.gov
Trial
- Title
- Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas
- NCT number
- NCT01434602
- Phases
- PHASE1, PHASE2
- Conditions
- Brain Tumor, Glioblastoma, Anaplastic Glioma
- Interventions
- everolimus, sorafenib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2022-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01434602?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01434602-3875badc