A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
2 other identifiers
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedNovember 18, 2023
November 1, 2023
3.9 years
December 18, 2018
November 16, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of adverse events and serious adverse events
Will assess clinical symptoms and laboratory values, evaluate vital signs and perform physical exams, with a special attention to treatment- related fatigue, gastrointestinal (GI) symptoms, cardiovascular events, myelosuppression, and neurotoxicity.
Up to 30 days after last dose
Incidence of >= grade 2 adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Up to 30 days after last dose
Dose-limiting toxicities
Up to 28 days
Withdrawals from the study due to treatment-related adverse events will be documented
Up to 30 days after last dose
Change of the treatment regimen such as dose delay and dose reduction over time by dose level due to treatment-related adverse events
Up to 30 days after last dose
Secondary Outcomes (3)
Objective responses
Up to 6 months
Clinical benefit
Up to 6 months
Predictive biomarkers
Up to 6 months
Study Arms (1)
Treatment (TRPV6 calcium channel inhibitor SOR-C13)
EXPERIMENTALPatients receive TRPV6 calcium channel inhibitor SOR-C13 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- To be eligible for this trial, patients must meet all of the following eligibility 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:
- Neutrophils ≥ 1,500 /L
- Platelets ≥ 100,000 /L
- Total bilirubin ≤ 1.5 x ULN (upper limit of normal) (except patients with Gilbert's syndrome, who must have a total bilirubin ≤ 3.0 mg/dL)
- ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases persist
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 45 mL/minute by the Cockcroft-Gault method
- Albumin ≥ 3.0 g/dL (≥30 g/L)
- INR (international normalized ratio) ≤1.4
- +3 more criteria
You may not qualify if:
- Patients who meet any of the following criteria will be not eligible for the study.
- 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.
- 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.
- \*Significant arrhythmias are defined as symptoms of syncope or severe palpitations (palpitations requiring referral to cardiac monitoring), or ECG findings of supraventricular tachycardia (including atrial fibrillation or atrial flutter) or ventricular tachycardia (including ventricular fibrillation) or ventricular ectopy (ventricular premature depolarization)
- 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.
- Major surgical procedure within 4 weeks prior to enrolment.
- Lactating or pregnant female.
- Females of childbearing potential and males not using adequate birth control.
- Current treatment or treatment within 4 weeks of screening with bisphosphonates.
- Hypocalcemia at screening.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siqing Fu
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 24, 2018
Study Start
July 29, 2019
Primary Completion
June 20, 2023
Study Completion
June 20, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11