Metastatic Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase 1B Study of Ribociclib in Combination With Doxorubicin in Advanced Soft Tissue Sarcomas
This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas. SECONDARY OBJECTIVES: I. To assess preliminary anti-tumor activity of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas. II. To characterize the safety and tolerability of ribociclib in combination with doxorubicin. OUTLINE: This is a dose-escalation study of ribociclib. Patients receive ribociclib orally (PO) daily on days 1-7, and doxorubicin hydrochloride intravenously (IV) on day 10. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients without disease progression after 6 cycles receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days and then every 12 weeks for 12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03670069 -
Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas
|
Phase 1 | |
| Recruiting |
NCT05075993 -
Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
|
Phase 1 | |
| Suspended |
NCT03793361 -
Phase II Study of Regorafenib as Maintenance Therapy
|
Phase 2 | |
| Withdrawn |
NCT03397186 -
Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma
|
Phase 2 | |
| Recruiting |
NCT03965234 -
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04028063 -
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
|
Phase 2 | |
| Active, not recruiting |
NCT04200443 -
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
|
Phase 2 | |
| Recruiting |
NCT05711615 -
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
|
Phase 1 | |
| Active, not recruiting |
NCT01514188 -
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT01574716 -
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
|
Phase 2 | |
| Completed |
NCT02500797 -
Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
|
Phase 2 | |
| Recruiting |
NCT03138161 -
SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03660930 -
Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
|
Phase 1/Phase 2 |