CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Sirolimus combined with CP, MT and ZAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02517918
NCT02517918Phase 1Completed
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Metronomic Cyclophosphamide and Methotrexate Combined With Zoledronic Acid and Sirolimus in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma. A Phase Ib Study From the French Sarcoma Group

Institut Bergonié·interventional·Posted Aug 7, 2015·Updated Jun 8, 2025

In Brief

A Phase 1 clinical trial evaluating Sirolimus combined with CP, MT and ZA for Solid Tumor and Osteosarcoma. Completed, enrolled 23 participants across 3 sites.

Detailed Summary

This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Osteosarcoma
CountriesFrance
CollaboratorsReliable Cancer Therapies, Pfizer

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 7, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 5, 2016
Study CompletionNov 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.9 years ago

Interventions

Sirolimus combined with CP, MT and ZAdrug

Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV). Trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the MTD is established.