A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors (NCT03784677) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
United States11 participantsStarted 2019-07-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects with a histologic diagnosis of solid tumor cancers of epithelial origin (metastatic epithelial ovarian, pancreatic and prostate cancers are preferred since these tumor types have TRPV6 overexpression).
✓. Subjects with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no limitation on the number or types of prior therapy.
✓. Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1).
✓. Men or women aged ≥ 18 years.
✓. Women of child-bearing potential (who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., hormonal, barrier device, or abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose the study agents.
✓. Patients must have an ECOG performance status of 0 to 1.
✓. Patients must have adequate organ functions as defined below:
✓. Patients should be able to read and fully understand the requirements of the trial, be willing to comply with all trial visits and assessments, and be willing and able to sign an IRB-approved written informed consent document.
Exclusion criteria
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (NYHA Class III or IV), or history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study enrollment.
What they're measuring
1
Incidence of adverse events and serious adverse events
Timeframe: Up to 30 days after last dose
2
Incidence of >= grade 2 adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeframe: Up to 30 days after last dose
3
Dose-limiting toxicities
Timeframe: Up to 28 days
4
Withdrawals from the study due to treatment-related adverse events will be documented
Timeframe: Up to 30 days after last dose
5
Change of the treatment regimen such as dose delay and dose reduction over time by dose level due to treatment-related adverse events
✕. History of clinically significant allergic reactions to the study drugs or their analogs, or any component of the products.
✕. Any treatment specific for systemic tumor control within 3 weeks prior to the initiation of the study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting less than 4 days, or failure to recover from toxic effects of any therapy prior to the study drug treatment.
✕. Patients who have not recovered from major surgical procedure, or significant traumatic injury (i.e., still need additional medical care for these issues).
✕. History of any of the following cardiovascular events or conditions within the past 6 months prior to enrolment: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, New York Heart Association Class ≥ II chronic heart failure, significant arrhythmia\*; QTcF interval \>430 msec or use of drugs that prolong the QT interval at screening; family history of long QT syndrome.
✕. Clinically significant and uncontrolled major medical condition(s) that places the subject at an unacceptably high risk for toxicities. These include, but are not limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary function, seizure disorder, or psychiatric illness.
✕. Current use of more than one antihypertensive medication.
✕. For patients receiving antihypertensive medication: systolic blood pressure \<120 mm Hg and/or diastolic blood pressure \<70 mm Hg at screening.