Trials Sponsors Conditions Drugs Pricing

Conditions

Solid Tumor

Keywords

AXL InhibitorSolid Tumor

Outcome Measures

Primary Outcomes (2)

Number of Participants with Adverse Events (AEs) as assessed by NCI-CTCAE v5.0
To assess AEs as criteria of safety of oral SLC-391
2 years
Maximum Tolerated Dose of SLC-391
To determine the maximum tolerated dose (MTD) of SLC-391
21 days

Secondary Outcomes (10)

Area under the plasma concentration versus time curve (AUC) of SLC-391
Day 1 predose through to Day 21 post-final dose
Maximum Observed Plasma Concentration (Cmax)
Day 1 predose through to Day 21 post-final dose
Time to the Maximum Observed Plasma Concentration (Tmax)
Day 1 predose through to Day 21 post-final dose
Terminal elimination half-life (t1/2)
Day 1 predose through to Day 21 post-final dose
Recommended Dose of SLC-391 for future trials
2 years
+5 more secondary outcomes

Study Arms (1)

Dose escalation

EXPERIMENTAL

The starting dose will be 25 mg/day and subsequent doses will be determined after an internal review by Data Review Committee of all available safety, PK and PD data from the minimum required number of subjects who complete cycle 1. All dose-escalation decisions and the rationale for progressing to the next cohort will be documented. A subject may continue treatment with SLC-391 in 21-day cycles until the treatment discontinuation criteria are met.

Drug: SLC-391

Interventions

SLC-391Drug

SLC-391 is an AXL inhibitor

Dose escalation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be 18 years of age or older at the time of signing the informed consent.
Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy that is advanced and/or metastatic or unresectable and for which standard or curative measures do not exist or are no longer effective.

Sponsors & Collaborators

SignalChem Lifesciences Corporation
Industrylead

Study Sites (3)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

The Ottawa Hospital Cancer Center

Ottawa, Ontario, K1H 8L6, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Study Officials

Zaihui Zhang, PhD
SignalChem Lifesciences Corporation
STUDY DIRECTOR

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

June 14, 2019

First Posted

You may not qualify if:

Prior use of any AXL inhibitor
Localised or metastatic prostate cancer subjects who are concurrently receiving abiraterone or enzalutamide. Those subjects on stable (\>3 months) anti-cancer hormonal therapy are allowed.
Refractory nausea and vomiting, chronic gastrointestinal (GI) diseases, GI bleeding, ulceration, or perforation within 12 weeks prior to the first dose of the study drug, or significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of the study drug.
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, stroke or subarachnoid hemorrhage, coagulopathy, deep vein thrombosis, pulmonary embolism in the 3 months prior to consent.
Uncontrolled hypertension (≥ 160/100 mmHg).
History of or ongoing symptomatic dysrhythmias, uncontrolled atrial or ventricular arrhythmias, or heart block (excluding 1st degree block, consisting of PR interval prolongation only). Controlled atrial fibrillation is allowed.
QTcF interval \> 480 msec.
Severe respiratory illness that significantly impacts functional status in daily life including a known history of active tuberculosis (Mycobacterium tuberculosis).
History of significant weight loss (≥ 7 kgs/15 lbs) within 4 weeks prior to the first dose of study drug.
History of primary immunodeficiency or those with known human immunodeficiency virus (HIV), or known active hepatitis B (HBV; including core antibody and surface antigen; AntiHBc and HBsAg, respectively) or hepatitis C (HCV) infection. Note: No testing for HIV, Hepatitis B or C is required unless mandated by a local health authority.
Active uncontrolled infection, or an unstable or severe intercurrent medical condition that requires treatment.
History of solid organ transplant or bone marrow transplant.
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 and jeopardises compliance with the protocol and study visits.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
History of prior malignancy, except for the following: curatively treated basal or squamous cell carcinoma of the skin (nonmelanoma skin cancer); cervical or vaginal intra-epithelial neoplasia; or noninvasive breast cancer in situ at screening. Subjects with other curatively treated malignancies who have had no evidence of metastatic disease and a \> 2-year disease-free interval may be enrolled after approval by the Medical Monitor or SignalChem Lifesciences (SLC) designee.
+2 more criteria

Safety Study of SLC-391 in Subjects With Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (1)

Dose escalation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (1)

Dose escalation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations