Loading clinical trials...

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

NCT02048371•Sarcoma Alliance for Research through Collaboration

View on ClinicalTrials.gov

Summary

Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.

Detailed Description

Eligibility

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
•Weight ≥ 15 kg (33 lb)
•Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
•WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A \& B may be WHO performance status 2
•At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
•All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
•Subject must be able to swallow and retain oral medication
•At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
•Adequate organ function within 14 days of registration
•Written, voluntary informed consent
+3 more criteria

Exclusion Criteria

•Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
•Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
•Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
•Concurrent, clinically significant, active malignancies within 12 months of study enrollment
•Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
•Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
•Patients who have received wide field radiotherapy ≤ 28 days (defined as \> 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation \< 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
•Patients who have received prior systemic therapy \< 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given \< 5 half-lives of last dose of treatment, or \< 14 days, whichever is greater
•Patients who have had prior autologous, or allogeneic bone marrow transplant
•Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v 4.0\] on repeated measurement) despite optimal medical management
+19 more criteria

Locations (18)

City of Hope National Medical Center

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Sarcoma Oncology Research Center

Santa Monica, California, United States

Stanford University

Stanford, California, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

H. Lee Moffitt

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Dana Farber/Partners Cancer Care

Boston, Massachusetts, United States

Mayo Clinic - Minnesota

Rochester, Minnesota, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

May 1, 2022

Completion Date

May 1, 2022

Last Updated

November 7, 2023

Enrollment

131

ACTUAL participants

Conditions

LiposarcomaOsteogenic SarcomaEwing/Ewing-like SarcomaRhabdomyosarcomaMesenchymal Chondrosarcoma

Interventions

Regorafenib

DRUG

Placebo

DRUG

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

NCT06541262

NeuroblastomaEwing Sarcoma+3 more

View study

RECRUITING

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

NCT07432932

SarcomaSarcoma, Leiomyo-, Adult+10 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

Inclusion Criteria

Exclusion Criteria

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells

Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)

Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Solid Tumors