Comparison · NCT01034631-e1e0a7d4
Combination Arm A: Everolimus + BNC105P vs Sequential Arm B:Everolimus Followed by BNC105P Monotherapy: Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
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. Combination Arm A: Everolimus + BNC105P vs Sequential Arm B:Everolimus Followed by BNC105P Monotherapy: Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone. Trial comparisons, record NCT01034631-e1e0a7d4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01034631-e1e0a7d4
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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 | 0.0145 | 0.00256 | 0.0776 | wilson | |
| Risk in group 2 | 0.0149 | 0.00264 | 0.0798 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000433 | -0.0664 | 0.0639 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.971 | 0.062 | 15.2 | log | |
| Odds ratio, group 1 over group 2 | 0.971 | 0.0595 | 15.8 | log | |
| Number needed to treat, for one fewer participant with the outcome on Combination Arm A: Everolimus + BNC105P than on Sequential Arm B:Everolimus Followed by BNC105P Monotherapy | 2,310 | 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 | Combination Arm A: Everolimus + BNC105P | Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m\^2 | 1 | 69 | OG000 |
| Group 2 | Sequential Arm B:Everolimus Followed by BNC105P Monotherapy | Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m\^2 | 1 | 67 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
- Description
Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
- NCT number
- NCT01034631
- Phases
- PHASE1, PHASE2
- Conditions
- Renal Cell Carcinoma
- Interventions
- Everolimus, BNC105P
- Lead sponsor
- Hoosier Cancer Research Network
- Results first posted
- 2017-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01034631?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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