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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Soricimed Biopharma Inc
Sponsor:
Information provided by (Responsible Party):
Soricimed Biopharma Inc
ClinicalTrials.gov Identifier:
NCT01578564
First received: April 13, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: SOR-C13
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Soricimed Biopharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma levels of SOR-C13 [ Time Frame: Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3 and 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOR-C13 Drug: SOR-C13
Intravenous solution for infusion, potential dose range 5.5 mg/kg to 44 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578564

Contacts
Contact: Nicholas G Fields, PhD 4167263404 nfields@cogeco.ca
Contact: Toney T Ilenchuk, MS, Ph.D. 9059387461 tilenchuk@soricimed.com

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77230-1402
Contact: Siqing Fu, MD, PhD         
Principal Investigator: Siqing Fu, MD, PhD         
Canada, Ontario
Juravinski Cancer Center Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Hal W Hirte, MD    905 387 9495 ext 64603      
Principal Investigator: Hal W Hirte, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Stephen Welch, MD         
Principal Investigator: Stephen Welch, MD         
Sponsors and Collaborators
Soricimed Biopharma Inc
Investigators
Study Director: Toney T Ilenchuk, MS, PhD Soricimed Biopharma Inc
  More Information

No publications provided

Responsible Party: Soricimed Biopharma Inc
ClinicalTrials.gov Identifier: NCT01578564     History of Changes
Other Study ID Numbers: SOR-C13 01
Study First Received: April 13, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Soricimed Biopharma Inc:
Cancer
Ovarian Cancer
TRPV6 Calcium channel

ClinicalTrials.gov processed this record on November 20, 2014