Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 Channel
Verified December 2014 by Soricimed Biopharma Inc
Information provided by (Responsible Party):
Soricimed Biopharma Inc
First received: April 13, 2012
Last updated: December 2, 2014
Last verified: December 2014
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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
|MD Anderson Cancer Center
|Houston, Texas, United States, 77230-1402 |
|Contact: Siqing Fu, MD, PhD |
|Principal Investigator: Siqing Fu, MD, PhD |
|Juravinski Cancer Center
|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
|London, Ontario, Canada, N6A 4L6 |
|Contact: Stephen Welch, MD |
|Principal Investigator: Stephen Welch, MD |
Soricimed Biopharma Inc
||Toney T Ilenchuk, MS, PhD
||Soricimed Biopharma Inc
No publications provided
||Soricimed Biopharma Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2012
||December 2, 2014
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by Soricimed Biopharma Inc:
ClinicalTrials.gov processed this record on May 29, 2015
TRPV6 Calcium channel