Comparison · NCT01184326-56d244b9
Dose Level 0: Everolimus 5mg + Pazopanib 600 mg vs Dose Level -1: Everolimus 5mg + Pazopanib 400 mg: Dose Limiting Toxicity (DLT) [Phase I Dose Finding]
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 0: Everolimus 5mg + Pazopanib 600 mg vs Dose Level -1: Everolimus 5mg + Pazopanib 400 mg: Dose Limiting Toxicity (DLT) [Phase I Dose Finding]. Trial comparisons, record NCT01184326-56d244b9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01184326-56d244b9
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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 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0.667 | 0.0641 | 0.939 | 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, for one more participant with the outcome on Dose Level 0: Everolimus 5mg + Pazopanib 600 mg than on Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 1.5 | 1.07 | 15.6 | from the risk difference interval |
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 0: Everolimus 5mg + Pazopanib 600 mg | Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal. | 2 | 3 | OG000 |
| Group 2 | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | Everolimus 5mg + Pazopanib 400 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal. | 0 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Dose Limiting Toxicity (DLT) [Phase I Dose Finding]
- Description
A DLT was defined as an adverse event (a) with treatment attribution of possible, probable, or definite, and (b) occurs during cycle 1, and (c) meets any of the following criteria: Grade 3 or 4 non-hematologic toxicity excluding: nausea/vomiting controlled with antiemetics, Grade 3 hypertension that resolves to ≤150/90 within 7 days with supportive care, and Grade 3 asymptomatic, clinically insignificant laboratory abnormalities (LDH, alkaline phosphatase due to bone metastases, and asymptomatic hypophosphatemia). Hematologic toxicity: Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, Grade 4 neutropenia which persists for \>7 days, Grade 4 neutropenia associated with fever \>38.5C; Hematologic toxicity excluded lymphopenia or anemia of any grade. Missing more than 5 days of planned doses for drug-related intolerable grade 2 toxicity;Toxicity related to therapy severe enough to require a dose-reduction.
- Time frame
- Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for DLT evaluation was the first 28 days of treatment.
- Population
- All phase I dose finding participants who received at least one dose of the study drug were evaluable for DLT.
Source ClinicalTrials.gov
Trial
- Title
- Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer
- NCT number
- NCT01184326
- Phases
- PHASE1
- Conditions
- Solid Tumor, Kidney Cancer
- Interventions
- pazopanib, everolimus
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2018-11-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01184326?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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