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

NCT01578564 | Completed Phase 1 DMC

• 1 other identifier: SOR-C13 01
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer; Ovarian Cancer; TRPV6 Calcium channel

Outcome Measures

Primary Outcomes (1)

• Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Over 21 days from initial administration

Secondary Outcomes (1)

• Plasma levels of SOR-C13

  Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3, 8 and 10

Study Arms (1)

SOR-C13

EXPERIMENTAL

Drug: SOR-C13

Interventions

SOR-C13 DRUG

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

SOR-C13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• hemoglobin ≥9.0 g/dL (≥5.6 mmol/L)
• white blood cells ≥3,000/mm³(≥3×10⁹/L)
• absolute neutrophil count ≥1,500/mm³ (≥1.5×10⁹/L)
• platelets ≥100,000/μL (≥100×10⁹/L)
• total bilirubin ≤1.5× upper limit of normal(ULN)
• AST/ALT/AP ≤2.5× ULN (ALT/AST ≤5.0x ULN in case of documented liver metastases
• creatinine ≤1.5× ULN
• albumin ≥3.0 g/dL (≥30 g/L)

You may not qualify if:

• 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

Sponsors & Collaborators

• Soricimed Biopharma Inc: lead

Study Sites (3)

MD Anderson Cancer Center

Houston, Texas, 77230-1402, United States

Location

Juravinski Cancer Center

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Interventions

SOR-C13

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Toney T Ilenchuk, MS, PhD

  Soricimed Biopharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

CA (2); US (1)