Solid TumoursPhase 1NCT02215850

Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours

A Phase 1 study testing SLC-0111 in people with Solid Tumours, run by Welichem Biotech Inc. at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 overexpressed on extracellular surfaces of hypoxic tumour cells but its expression is highly restricted in normal… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumours
What is being tested?: SLC-0111
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesCanada
Study dates: Oct 2014to Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 27Show fewer

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Alberta Health Services - Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Conditions: Solid Tumours
Being tested: SLC-0111

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLC-0111Drug

Study groups in NCT02215850
Study group	Role	What they receive
SLC-0111	Experimental	Not described Receives: Drug: SLC-0111

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
To evaluate the safety and tolerability of SLC-0111, administered once daily, in subjects with advanced solid tumours.
Measured: 1 year. Subjects will continue to receive SLC-0111 for multiple cycles of 28 days if they are receiving benefit from therapy.

Secondary outcomes (1)

Area under the plasma concentration versus time curve (AUC) of SLC-0111
Changes in AUC over time in subjects taking SLC-0111 once daily.
Measured: 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Mar 2016

First posted13 Aug 2014 (estimated)
Study startOct 2014
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumoursStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02215850
Sponsor's protocol ID: OZM-055/SLC0111-14-C01
Status last verified: May 2016
First submitted: 11 Aug 2014
Last updated: 17 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumours trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02215850
Acronym / sponsor ID: OZM-055/SLC0111-14-C01
Conditions: Solid Tumours
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Welichem Biotech Inc.Industry (pharma, biotech, devices)
Collaborators: Ozmosis Research Inc.
Study start: Oct 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 13 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SLC-0111	Experimental	Drug: SLC-0111

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SLC-0111	Drug	SLC-0111

Primary outcome

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.

1 secondary outcome

Area under the plasma concentration versus time curve (AUC) of SLC-0111
Time frame: 1 year.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.

Related trials for Solid Tumours

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SLC-0111 in people with Solid Tumours, run by Welichem Biotech Inc. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02215850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.