drugset / Trial / NCT02517918

Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma

NCT02517918

NaSequentialOpen-labelTreatment

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.

Timeline

Start
2015-02
Primary completion
2016-09-05
Completion
2021-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule Oral
Background Cyclophosphamide Other / unclassified Oral
Background Methotrexate Small molecule Oral
Background Zoledronic acid Other / unclassified Intravenous

Indications