Comparison · NCT01217411-f339f5a1
Phase I Arm I vs Phase 1 Arm II: Response Rate (Complete or Partial Response)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Phase I Arm I vs Phase 1 Arm II: Response Rate (Complete or Partial Response). Trial comparisons, record NCT01217411-f339f5a1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01217411-f339f5a1
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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 | 1 | 0.439 | 1 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.561 | 0.658 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| 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 | Phase I Arm I | Arm 1: Patients with 4 or more lesions will receive Whole Brain Radiation Therapy (WBRT) combined with R04929097 (study drug) 1st cohort: Starting dose of 5mg (2nd cohort 10mg, 3rd cohort 20mg) (3 days on/4 days off continuous) 1 day prior to beginning WBRT | 3 | 3 | OG000 |
| Group 2 | Phase 1 Arm II | Arm 2: Patients with less than 4 lesions will receive Stereotactic Radiosurgery (SRS) combined with R04929097 (study drug). 1st cohort: starting dose of 5mg (2nd cohort 10mg, 3rd cohort 20 mg) (3 days on/4 days off continuous) 3 days prior to SRS) | 2 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Response Rate (Complete or Partial Response)
- Description
Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/\>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): \>25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or \> new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.
- Time frame
- 12 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
- NCT number
- NCT01217411
- Phases
- PHASE1, PHASE2
- Conditions
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive, Male Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Recurrent Melanoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
- Interventions
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Stereotactic Radiosurgery, Whole-Brain Radiotherapy
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01217411?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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