Clinical Trials Directory

Trials / Completed

CompletedNCT03784677

A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
11 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of SOR-C13 in treating patients with solid tumors that have spread to other places in the body (advanced) and does not respond to treatment. Drugs used in chemotherapy, such as SOR-C13, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed 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 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.

Conditions

Interventions

TypeNameDescription
DRUGTRPV6 Calcium Channel Inhibitor SOR-C13Given IV

Timeline

Start date
2019-07-29
Primary completion
2023-06-20
Completion
2023-06-20
First posted
2018-12-24
Last updated
2023-11-18

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03784677. Inclusion in this directory is not an endorsement.