Comparison · NCT02517918-09cfb040
Dose Escalation Part With Sirolimus (Si) Dose 4 mg vs Dose Escalation Part With Sirolimus (SI) Dose 6 mg: Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS)
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. Dose Escalation Part With Sirolimus (Si) Dose 4 mg vs Dose Escalation Part With Sirolimus (SI) Dose 6 mg: Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS). Trial comparisons, record NCT02517918-09cfb040. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02517918-09cfb040
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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 | 0.61 | 1 | wilson | |
| Risk in group 2 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | 0.667 | 0.0641 | 0.939 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.606 | 14.9 | log | |
| 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 Escalation Part With Sirolimus (Si) Dose 4 mg than on Dose Escalation Part With Sirolimus (SI) Dose 6 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 Escalation Part With Sirolimus (Si) Dose 4 mg | Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.~Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.~Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.~Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.~Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks. | 6 | 6 | OG000 |
| Group 2 | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.~Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.~Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.~Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.~Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks. | 1 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS)
- Description
1-year Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Time frame
- 1-year Progression-free survival (PFS) as per RECIST v1.1
- Population
- Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1.
Source ClinicalTrials.gov
Trial
- Title
- Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
- NCT number
- NCT02517918
- Phases
- PHASE1
- Conditions
- Solid Tumor, Osteosarcoma
- Interventions
- Sirolimus combined with CP, MT and ZA
- Lead sponsor
- Institut Bergonié
- Results first posted
- 2025-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02517918?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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