Advanced Malignant Solid NeoplasmPhase 1NCT03784677
A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
A Phase 1 study testing TRPV6 Calcium Channel Inhibitor SOR-C13 in people with Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Ovarian Carcinoma
- What is being tested?
- TRPV6 Calcium Channel Inhibitor SOR-C13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2019to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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.
- Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment.
- Patients agree to provide archival tissue block or 10 formalin-fixed paraffin-embedded (FFPE) slides paraffin for use in pharmacodynamics correlative studies.
Who cannot join
- 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.
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- 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.
- History of acute pancreatitis within 6 months prior to screening.
- Known hypoparathyroidism, pseudohypoparathyroidism, or vitamin D deficiency, or clinical evidence of other conditions known to associated with hypocalcemia, including hypoalbuminemia, hyperphosphatemia, hypomagnesemia.
- Current treatment or treatment within 4 weeks of screening with drugs known to reduce serum calcium levels, including: bisphosphonates, antiepileptic drugs, cinacalcet, macrolide antibiotics (such as erythromycin, azithromycin), large doses of corticosteroids (>20 mg/day of prednisone or equivalent), or any IV use of corticosteroids. In addition, long-term use (defined as ongoing use for ≥4 weeks) of corticosteroids within 8 weeks of screening is prohibited.
- Symptomatic and uncontrolled metastasis to the central nervous system or leptomeningeal or lymphangitic carcinomatosis.
- Grade 2 or higher peripheral neuropathy.
- Human immunodeficiency virus requiring HAART treatment due to unknown drug-drug interactions or known active hepatitis B or C.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Ovarian Carcinoma, Refractory Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8
- Being tested
- TRPV6 Calcium Channel Inhibitor SOR-C13
- Medical subject headings
- Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPV6 Calcium Channel Inhibitor SOR-C13Drug
Also called SOR-C13
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TRPV6 calcium channel inhibitor SOR-C13) | Experimental | Patients 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. Receives: Drug: TRPV6 Calcium Channel Inhibitor SOR-C13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 30 days after last dose
Dose-limiting toxicities
Measured: Up to 28 days
Withdrawals from the study due to treatment-related adverse events will be documented
Measured: 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
Measured: Up to 30 days after last dose
Secondary outcomes (3)
Objective responses
Defined as complete response(CR)s and partial response (PR).
Measured: Up to 6 months
Clinical benefit
Defined as stable disease (SD)/CR/PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 6 months
Predictive biomarkers
Fisher exact test is used to associate potential biomarkers with SD >= 6 months/CR/PR. Next generation sequencing for targeted exome panel and NanoString arrays are used to reveal potential biomarkers of acquired resistance.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start29 Jul 2019
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784677
- Sponsor's protocol ID
- 2018-0680
- Other IDs
- NCI-2018-02835, 2018-0680
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03784677
- Acronym / sponsor ID
- 2018-0680
- Conditions
- Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Ovarian Carcinoma, Refractory Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TRPV6 calcium channel inhibitor SOR-C13) | Experimental | Drug: TRPV6 Calcium Channel Inhibitor SOR-C13Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRPV6 Calcium Channel Inhibitor SOR-C13Also: SOR-C13Given IV | Drug | Treatment (TRPV6 calcium channel inhibitor SOR-C13) |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: Up to 30 days after last dose
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.
Incidence of >= grade 2 adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Up to 30 days after last dose
Dose-limiting toxicities
Time frame: Up to 28 days
Withdrawals from the study due to treatment-related adverse events will be documented
Time frame: 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
Time frame: Up to 30 days after last dose
3 secondary outcomes
Objective responses
Time frame: Up to 6 months
Clinical benefit
Time frame: Up to 6 months
Predictive biomarkers
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siqing Fu principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRPV6 Calcium Channel Inhibitor SOR-C13 in people with Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: Up to 30 days after last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.