Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-03-06 @ 12:01 PM
Study NCT ID:
NCT02517918
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2015-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METZOLIMOS
Brief 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.
Detailed Description:
The dose escalation part of the trial will be concerned on adults with advanced solid tumor with bone metastasis and young and adult patients with unresectable locally advanced or metastatic osteosarcoma.
The Expansion cohort will be conducted on young and adult patients with unresectable locally advanced or metastatic osteosarcoma.
The Expansion cohort will be conducted on young and adult patients with unresectable locally advanced or metastatic osteosarcoma.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: