SOR-C13 in Treating Patients With Advanced Refractory Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage III Prostate Cancer AJCC v8
- Advanced Malignant Solid Neoplasm
- Stage IV Ovarian Cancer AJCC v8
- Refractory Malignant Solid Neoplasm
- Refractory Ovarian Carcinoma
- Refractory Pancreatic Carcinoma
- Stage II Pancreatic Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
- Stage IIA Pancreatic Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIB Pancreatic Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To define the maximum tolerated doses (MTD) of TRPV6 calcium channel inhibitor SOR-C13 (SOR-C13) in subjects with advanced solid tumor cancers of epithelial origin. II. To define the safety profiles of the treatment. SECONDARY OBJECTIVES: I. To evaluate clinical response signa...
PRIMARY OBJECTIVES: I. To define the maximum tolerated doses (MTD) of TRPV6 calcium channel inhibitor SOR-C13 (SOR-C13) in subjects with advanced solid tumor cancers of epithelial origin. II. To define the safety profiles of the treatment. SECONDARY OBJECTIVES: I. To evaluate clinical response signals to the treatment. II. To assess predictive biomarkers (baseline molecular mutation status) and/or resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses. OUTLINE: This is a dose-escalation study. Patients receive TRPV6 calcium channel inhibitor SOR-C13 intravenously (IV) over 2 hours on days 1, 2, 8, 9, 15, 16, 22, and 23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT03784677
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Siqing Fu M.D. Anderson Cancer Center
Get Well Soon