Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.
PRIMARY OBJECTIVES:
I. To determine the progression-free survival (defined as complete response [CR] + partial
response [PR] + stable disease [SD]) assessed at 16 weeks for patients treated with
tivozanib.
SECONDARY OBJECTIVES:
I. Overall response rate (defined as CR + PR). II. Clinical benefit rate (CR + PR + SD). III.
Overall survival (up to 2 years beyond progression). IV. Correlation of clinical outcome with
antibodies for vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2.
V. Assess Safety and tolerability.
OUTLINE:
Patients receive tivozanib orally (PO) daily on days 1-21. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity, or until discontinuation per
patient preference or physician recommendation.
After completion of study treatment, patients are followed up every 3 months for 2 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00245102 -
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
|
Phase 2 | |
| Completed |
NCT01222715 -
Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
|
Phase 2 | |
| Completed |
NCT01206140 -
Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT01553539 -
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT00098579 -
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
|
Phase 1 | |
| Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
| Completed |
NCT01462630 -
Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
|
Phase 2 | |
| Completed |
NCT01016015 -
Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
|
Phase 2 | |
| Terminated |
NCT00087191 -
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
|
N/A | |
| Completed |
NCT00084630 -
Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans
|
Phase 2 | |
| Completed |
NCT02357810 -
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
|
Phase 2 | |
| Terminated |
NCT00233948 -
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
| Completed |
NCT00919269 -
Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
|
||
| Completed |
NCT01532687 -
Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT01154452 -
Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00937495 -
Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT00720174 -
Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
|
Phase 1 | |
| Completed |
NCT00330421 -
Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)
|
Phase 2 | |
| Completed |
NCT00087074 -
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
|
Phase 2 |