Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01281865

Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma

Recurrent Adult Soft Tissue Sarcoma Clinical Trial

Official title:
A Phase 1b/2 Study of Imatinib in Combination With Everolimus in Synovial Sarcoma

Clinical Trial Summary

This phase I/II clinical trial is studying the side effects and best dose of everolimus when given with imatinib mesylate and to see how well they work in treating patients with locally advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose (MTD) of everolimus in combination with imatinib mesylate in patients with synovial sarcoma. (Phase I) II. To determine the overall response rate (RR = CR + PR). (Phase II)

SECONDARY OBJECTIVES:

I. To determine RR, progression-free survival (PFS), and overall survival (OS). (Phase I) II. To determine predictors of response. (Phase II) III. To obtain tissue biopsy and plasma samples for correlative studies pre- and post-treatment. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of everolimus followed by a phase II study.

Patients receive everolimus orally (PO) once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies.

After completion of study therapy, patients are followed up for 30 days. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01281865
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2011
Completion date October 2013
View Details
See also
  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 NCT01782313 - A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas 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