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History of Changes for Study: NCT02215850
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
Latest version (submitted May 13, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 11, 2014 None (earliest Version on record)
2 November 6, 2014 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 11, 2014 Study Description and Study Status
4 December 5, 2014 Contacts/Locations and Study Status
5 November 16, 2015 Study Status
6 December 8, 2015 Study Status, Eligibility and Study Design
7 December 17, 2015 Sponsor/Collaborators, Study Identification and Study Status
8 May 13, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02215850
Submitted Date:  August 11, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: OZM-055/SLC0111-14-C01
Brief Title: Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
Official Title: A Phase I, Multi-center, Open-label, Study to Investigate the Safety, Tolerability and Pharmacokinetic of SLC-0111 in Subjects With Advanced Solid Tumours
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2014
Overall Status: Not yet recruiting
Study Start: October 2014
Primary Completion: October 2015 [Anticipated]
Study Completion: March 2016 [Anticipated]
First Submitted: August 11, 2014
First Submitted that
Met QC Criteria:
August 11, 2014
First Posted: August 13, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 11, 2014
Last Update Posted: August 13, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: SignalChem Lifesciences Corporation
Responsible Party: Sponsor
Collaborators: Ozmosis Research Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28 day cycles in subjects with advanced solid tumours. The intent of this research study is to find our more information such as: the highest dose of SLC-0111 that can be given safely, the side effect it may cause, to examine how the body affects the study drug concentration in the blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating cancer.
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumours
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 34 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SLC-0111 Drug: SLC-0111
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events
[ Time Frame: 1 year. Subjects will continue to receive SLC-0111 for multiple cycles of 28 days if they are receiving benefit from therapy. ]

To evaluate the safety and tolerability of SLC-0111, administered once daily, in subjects with advanced solid tumours.
Secondary Outcome Measures:
1. Area under the plasma concentration versus time curve (AUC) of SLC-0111
[ Time Frame: 1 year. ]

Changes in AUC over time in subjects taking SLC-0111 once daily.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Males or females aged ≥ 18 years old.
  2. Able and willing to provide written informed consent and to comply with the study protocol and procedures.
  3. Histological or cytological evidence of advanced and/or metastatic or unresectable tumour(s) for which standard curative measures do not exist.
  4. Recovery to ≤ Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1.
  6. Life expectancy greater than 3 months in the Investigator's opinion.
  7. 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, 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.
  8. 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.
  9. Adequate hepatic function:
    • Serum bilirubin ≤1.5 times upper limit of normal (ULN)
    • AST and 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]).
  10. Adequate bone marrow function:
    • Absolute neutrophil count ≥1.5 x 109/L
    • Platelets ≥100 x 109/L
    • Haemoglobin ≥90 g/L
  11. Adequate coagulation tests: international normalised ratio (INR) ≤1.5 x ULN.
  12. Corrected QT interval (QTcB) < 470 ms
  13. Ability to take oral liquid medication
  14. 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).
  15. Sexually-active women of child-bearing potential and sexually-active male subjects with a female partner of child-bearing potential must agree to use acceptable methods of contraception to avoid pregnancy before the first dose of study therapy and for 3 months after the last dose of study therapy.

    Additional Inclusion Criteria for Dose Expansion Phase:

  16. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Exclusion Criteria:

  1. Prior treatment with any drugs known to inhibit hypoxia (drugs that function under hypoxia and drugs that target cells in hypoxic regions are allowed).
  2. Females who are pregnant, planning to become pregnant or breastfeeding.
  3. 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.
  4. 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 (DBP) ≥90 mmHg, or left ventricular ejection fraction (LVEF) <50%.
  5. Any condition or illness that, in the opinion of the Investigator or the Medical Monitor, would compromise subject safety or interfere with the evaluation of the safety of the study drug.
  6. Subjects with documented cases of human immunodeficiency virus (HIV), or hepatitis B or C.
  7. Concurrent treatment with warfarin (Coumadin).
  8. 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.
  9. Gastrointestinal condition which could interfere with the swallowing or absorption of study medication.
  10. 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.

    Additional Exclusion Criteria:

  11. Enrolled in the dose escalation phase of the current study.
Open or close this module Contacts/Locations
Central Contact Person: Ben Boyd
Telephone: 416-673-8436
Email: ben.boyd@ozmosisresearch.ca
Locations: Canada, Alberta
Alberta Health Services - Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Contact:Principal Investigator: Quincy Chu, MD
Contact:Sub-Investigator: Michael Sawyer, MD
Contact:Sub-Investigator: Randeep Sangha, MD
Contact:Sub-Investigator: Jennifer Spratlin, MD
Contact:Sub-Investigator: Peter Venner, MD
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Contact:Principal Investigator: Stephen Chia, MD
Contact:Sub-Investigator: Karen Gelmon, MD
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Contact:Principal Investigator: Philippe Bedard, MD
Contact:Sub-Investigator: Lillian Siu, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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