Comparison · NCT02495103-200edafa
Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: Phase 1 Component - 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 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT). Trial comparisons, record NCT02495103-200edafa. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02495103-200edafa
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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 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.49 | 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 | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib | 0 | 3 | OG000 |
| Group 2 | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib | 0 | 4 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT)
- Description
A DLT is defined as grade III or greater diarrhea leading to hospitalization or lasting \> 48 hours despite optimal anti-diarrheal medication; grade IV diarrhea despite optimal anti-diarrheal prophylaxis; grade III or greater nausea or vomiting despite optimal antiemetics; grade III hypertension that is not controlled (to 140/90 mmHg or below) despite optimal antihypertensive therapy; grade III elevated serum creatinine that cannot be corrected to grade 1 or better with hydration within 48 hours; and electrolyte abnormalities that cannot be corrected with medical management within 72 hours.
- Time frame
- Cycle 1 or 42 days from the time the intended dose of metformin is reached for a given dose level
- Population
Source ClinicalTrials.gov
Trial
- Title
- Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
- NCT number
- NCT02495103
- Phases
- PHASE1, PHASE2
- Conditions
- Renal Cell Carcinoma, Hereditary Leiomyomatosis, Renal Cell Cancer
- Interventions
- Vandetanib, Metformin, Vandetanib/Metformin
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-01-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02495103?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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GET https://conductscience.org/api/comparisons/v1/NCT02495103-200edafa