Status:
COMPLETED
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
Lead Sponsor:
Welichem Biotech Inc.
Collaborating Sponsors:
Ozmosis Research Inc.
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane metalloenzyme, is...
Eligibility Criteria
Inclusion
- Males or females aged ≥ 18 years old.
- Able and willing to provide written informed consent and to comply with the study protocol and procedures.
- Histological or cytological evidence of advanced and/or metastatic or unresectable tumour(s) for which standard curative measures do not exist.
- Recovery to ≤ Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 3 months in the Investigator's opinion.
- The following time must have elapsed between previous therapy for cancer and first administration of SLC-0111:
- At least 4 weeks since previous cancer-directed therapy (cytotoxic agents, targeted therapy including monoclonal antibody therapy, immunotherapy, hormonal therapy, and prior radiotherapy).
- At least 4 weeks or five times the elimination half-life (whichever is shortest) of any investigational drug/biologic or combination product prior to first dose of study treatment.
- At least 3 months since prior interferon therapy.
- At least 4 weeks since any major surgery
- At least 12 weeks since any incidence of severe gastrointestinal bleeding.
- Adequate renal function:
- • Creatinine ≤1.5 times upper limit of normal (ULN) or calculated creatinine clearance (CrCl) using the Cockcroft Gault formula ≥60 mL/min, or measured CrCl ≥60 mL/min.
- Adequate hepatic function:
- Serum bilirubin ≤1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver lesions present \[i.e. liver metastasis or primary tumour of the liver for hepatocellular carcinoma (HCC\]).
- Adequate bone marrow function:
- Absolute neutrophil count ≥1.5 x 109/L
- Platelets ≥100 x 109/L
- Haemoglobin ≥90 g/L
- Adequate coagulation tests: international normalised ratio (INR) ≤1.5 x ULN.
- Corrected QT interval (QTcB) \< 470 ms
- Ability to take oral liquid medication
- Negative urine pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy/oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).
- Sexually-active women of child-bearing potential and sexually-active male subjects with a female partner of child-bearing potential or pregnant must agree to use acceptable double-barrier methods of contraception to avoid pregnancy from screening, for the duration of the study, and for 4 months after the last dose of study drug (Rhythm methods and/or abstinence will not be considered as highly effective methods of birth control).
- Subjects must agree not to donate gametes (i.e. sperms and eggs) during the study and for 4 months following their last dose of SLC-0111.
Exclusion
- Prior treatment with any drugs known to inhibit hypoxia (drugs that function under hypoxia and drugs that target cells in hypoxic regions are allowed).
- Females who are pregnant, planning to become pregnant or breastfeeding.
- Known central nervous system metastasis that is symptomatic and/or requires treatment. Radiographically stable lesions for 3 months prior to enrollment that were previously treated with steroids are permitted as long as they are not currently being treated with steroids.
- History of myocardial infarction, unstable angina, congestive heart failure (New York Heart Association class III/IV), cerebrovascular accident, transient ischaemic attack, limb claudication at rest in the 6 months prior to the first administration of SLC-0111, or ongoing symptomatic dysrhythmias, or uncontrolled atrial or ventricular arrhythmias, or uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg, or left ventricular ejection fraction (LVEF) \<50%.
- Any condition or illness that, in the opinion of the Investigator would compromise subject safety or interfere with the evaluation of the safety of the study drug.
- Subjects with documented cases of human immunodeficiency virus (HIV), or hepatitis B or C.
- Concurrent treatment with warfarin (Coumadin).
- Known allergy to study drug or its excipients (PEG 200, PEG 400, Soy lecithin, Vitamin E TPGS, and Propylene glycol) or severe allergy to other sulfonamides.
- Gastrointestinal condition which could interfere with the swallowing or absorption of study medication.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, gastrointestinal bleeding, ulceration, or perforation within 12 weeks prior to the first administration of SLC-0111 or significant bowel resection that would preclude adequate absorption.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02215850
Start Date
October 1 2014
End Date
March 1 2016
Last Update
May 17 2016
Active Locations (3)
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1
Alberta Health Services - Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
2
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9