Metastatic Soft Tissue Sarcoma Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects. Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1.[28] Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan Meier method.[30] Evaluation of 4- and 6-month progression-free survival will also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 4.0 (published 28 May 2009). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| Completed |
NCT03009201 -
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery
|
Phase 1 | |
| 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 | |
| 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 |