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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578564
• Other study ID #: SOR-C13 01
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2012
• Last updated: June 21, 2016
• Start date: July 2012
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Soricimed Biopharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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(=3×10?/L)

3. absolute neutrophil count =1,500/mm³ (=1.5×10?/L)

4. platelets =100,000/µL (=100×10?/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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Juravinski Cancer Center	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Soricimed Biopharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0		Over 21 days from initial administration	Yes
Secondary	Plasma levels of SOR-C13		Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3, 8 and 10	No