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Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 Channel

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ClinicalTrials.gov Identifier: NCT01578564
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Soricimed Biopharma Inc

Tracking Information
First Submitted Date  ICMJE April 13, 2012
First Posted Date  ICMJE April 17, 2012
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Over 21 days from initial administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Plasma levels of SOR-C13 [ Time Frame: Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3, 8 and 10 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Plasma levels of SOR-C13 [ Time Frame: Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3 and 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 Channel
Official Title  ICMJE Phase I, Open-label, Dose Escalation Study to Assess Safety and Tolerability of SOR-C13 in Subjects With Advanced Solid Tumors Commonly Known to Express the TRPV6 Ion Channel
Brief Summary The purpose of this study is to determine the safety and tolerability of the drug SOR-C13 when given as an intravenous infusion in patients with ovarian cancer or other cancers known to over express the TRPV6 calcium channel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: SOR-C13
Intravenous solution for infusion, potential dose range 1.375 mg/kg to 6.12 mg/kg, dosing frequency 2 cycles with a cycle consisting of infusions on days 1-3 and days 8-10 followed by a 11 day off period
Study Arms  ICMJE Experimental: SOR-C13
Intervention: Drug: SOR-C13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2012)
30
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Males and females ≥ 18 years of age
  • Subjects with a histologic diagnosis of solid tumor cancers of epithelial origin.
  • 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.
  • 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.
  • ECOG (Eastern Cooperative Oncology Group) Performance Score ≤ 1.
  • Life expectancy of greater than 12 weeks.
  • Subjects must have adequate organ and marrow function as defined below:

    1. hemoglobin ≥9.0 g/dL (≥5.6 mmol/L)
    2. white blood cells ≥3,000/mm³(≥3×10⁹/L)
    3. absolute neutrophil count ≥1,500/mm³ (≥1.5×10⁹/L)
    4. platelets ≥100,000/μL (≥100×10⁹/L)
    5. total bilirubin ≤1.5× upper limit of normal(ULN)
    6. AST/ALT/AP ≤2.5× ULN (ALT/AST ≤5.0x ULN in case of documented liver metastases
    7. creatinine ≤1.5× ULN
    8. albumin ≥3.0 g/dL (≥30 g/L)
    9. INR ≤1.4
  • Ability to understand and voluntarily sign the informed consent document

Exclusion Criteria:

  • Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 30 days, or 5 half lives (whichever is longer) prior to study drug administration.
  • History or clinical evidence of central nervous system (CNS) tumor involvement (metastases) or other known clinically relevant CNS pathology (e.g., epilepsy, seizure, paresis, aphasia, cerebellar disease, severe brain injury, psychosis).
  • Concurrent malignancy other than the solid tumor under investigation, requiring active treatment.
  • History of clinically significant allergic reaction attributed to any injected compound.
  • 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, hypokalemia, significant arrhythmia*; 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 ECG findings of supraventricular 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, psychiatric illness.
  • Current use of more than one antihypertensive medication.
  • For patients receiving antihypertensive medication:systolic blood pressure < 120 mmHg and/or diastolic blood pressure < 70 mmHg 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 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.
  • Screening serum calcium levels < 2.20 mmol/L [8.8 mg/dL] (after correction for serum albumin
  • History of acute pancreatitis within 12 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
  • Any history of a venous thromboembolic event (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Current treatment or treatment within 7 days of screening with a vitamin K antagonist, such as warfarin. Patients who require anticoagulation due to their central line may receive an alternative agent, such as low molecular weight heparin (LMWH).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578564
Other Study ID Numbers  ICMJE SOR-C13 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soricimed Biopharma Inc
Study Sponsor  ICMJE Soricimed Biopharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Toney T Ilenchuk, MS, PhD Soricimed Biopharma Inc
PRS Account Soricimed Biopharma Inc
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP