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SOR-C13 in Treating Patients With Advanced Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT03784677
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 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.

Condition or disease Intervention/treatment Phase
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 Stage IIB Pancreatic Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Drug: TRPV6 Calcium Channel Inhibitor SOR-C13 Phase 1

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. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : August 9, 2022
Estimated Study Completion Date : August 9, 2022


Arm Intervention/treatment
Experimental: Treatment (TRPV6 calcium channel inhibitor SOR-C13)
Patients receive TRPV6 calcium channel inhibitor SOR-C13 IV over 2 hours on days 1, 2, 8, 9, 15, 16, 22, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: TRPV6 Calcium Channel Inhibitor SOR-C13
SOR-C13, a TRPV6 calcium channel inhibitor will be given as intravenous (IV) infusion, on days 1 and 2 every week until disease progresses or unacceptable toxicity.
Other Name: SOR-C13




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 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 4.0 [ Time Frame: Up to 30 days after last dose ]
  3. Dose-limiting toxicities [ Time Frame: Up to 28 days ]
  4. Change of the treatment regimen determined by treatment-related adverse events [ Time Frame: Up to 30 days after last dose ]
  5. Maximum tolerated dose (MTD) will be defined by DLTs that occur in the first 28 days. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 6 months ]
    Objective Response Rate defined as complete response(CR)s and partial response (PR)

  2. Clinical benefit defined as stable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Neutrophils >= 1,500 /uL
  • Platelets >= 100,000 /uL
  • 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)
  • Alanine aminotransferase (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 (>= 3.0 g/L)
  • International normalized ratio (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 Institutional Review Board (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

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association [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 enrollment: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, New York Heart Association class >= II chronic heart failure, hypokalemia, significant arrhythmia

    • Corrected QC (QTc) 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 electrocardiography (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
  • A known diagnosis of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), acute or chronic hepatitis B or hepatitis C infection, as determined by medical history
  • Major surgical procedure within 4 weeks prior to enrollment
  • 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
  • Known human immunodeficiency virus infection (HIV), active hepatitis B or C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784677


Locations
United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Siqing Fu    713-563-0181      
Principal Investigator: Siqing Fu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Siqing Fu M.D. Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03784677     History of Changes
Other Study ID Numbers: 2018-0680
NCI-2018-02835 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0680 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Carcinoma
Genital Diseases, Male
Prostatic Diseases
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs