Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04220229|
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma of the Extremity Stage I Soft Tissue Sarcoma of the Trunk and Extremities Stage IA Soft Tissue Sarcoma of the Trunk and Extremities Stage IB Soft Tissue Sarcoma of the Trunk and Extremities Stage II Soft Tissue Sarcoma of the Trunk and Extremities||Drug: Cabozantinib S-malate Radiation: Radiation Therapy||Phase 1 Phase 2|
OUTLINE: This is a phase I, dose-escalation study of cabozantinib followed by a phase II, dose-expansion study.
Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 2, patients also undergo standard of care radiation therapy for 5-6 weeks.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, then every 6 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Neoadjuvant Cabozantinib in Combination With Radiation Therapy for Sarcomas of the Extremities|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2025|
Experimental: Treatment (cabozantinib S-malate, radiation therapy)
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 2, patients also undergo standard of care radiation therapy for 5-6 weeks.
Drug: Cabozantinib S-malate
Radiation: Radiation Therapy
Undergo standard of care radiation therapy
- Recommended phase 2 dose of cabozantinib S-malate (cabozantinib) (Phase I) [ Time Frame: Up to 21 days ]
- Rate of relapse (Phase II) [ Time Frame: At 12 months after treatment initiation ]
- Rate of pathologic response [ Time Frame: Up to 1 year ]
- Rate of surgical excision with negative margins [ Time Frame: Up to 1 year ]
- Response rate (complete, partial, overall) [ Time Frame: Up to 1 year ]Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Pattern of and time to local versus (vs.) distant recurrences [ Time Frame: Up to 3 years ]
- Relapse-free and overall survival [ Time Frame: Up to 1 year ]
- Incidence of adverse events [ Time Frame: Up to 28 days after last dose of investigational product ]Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Rate of treatment discontinuation prior to neoadjuvant radiation therapy [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220229
|Contact: Roxanne Moorefirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Roxanne Moore 206-606-6425 email@example.com|
|Principal Investigator: Lee Cranmer|
|Principal Investigator:||Lee Cranmer||Fred Hutch/University of Washington Cancer Consortium|