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Anti-metabolites

SLC-0111 + Gemcitabine for Pancreatic Cancer (SLC-0111-17-01 Trial)

Phase 1 & 2

Waitlist Available

Led By Daniel J Renouf, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A biopsiable tumour and a willingness to provide biopsies if no archival tumour tissue exists

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

Must not have

Females who are pregnant, planning to become pregnant or breastfeeding

Severe cardiac disease which has required hospitalization within the past 3 months or which functionally limits a patient

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, SLC-0111, to see if it is safe and effective when given with gemcitabine to people with a certain type of pancreatic cancer.

Who is the study for?

This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma that's spread beyond the pancreas but not to local lymph nodes. Participants must have tumors positive for CAIX, be able to give a biopsy if no old tissue samples exist, and have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work.

What is being tested?

The study tests SLC-0111 taken orally alongside IV gemcitabine injections in two parts: first finding the right dose (Dose Escalation) and then giving this dose to more people (Dose Expansion). It aims to see how well these drugs work together against advanced pancreatic cancer.

What are the potential side effects?

Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, lowered blood cell counts leading to increased infection risk, liver function changes, and potential allergic reactions related specifically to SLC-0111.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to provide a biopsy if no old cancer tissue samples exist.

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My kidney function is within the normal range.

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I can take pills and don't have major stomach issues affecting medicine absorption.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am not pregnant.

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My blood counts meet the required levels without needing medication to boost them.

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My liver tests are within the required range.

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I have recovered from previous cancer treatments, except for hair loss.

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My pancreatic cancer has spread and was confirmed by a lab test.

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My cancer tissue tests positive for CAIX.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, planning to become pregnant, or breastfeeding.

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I have severe heart problems that needed hospital care recently or limit my activities.

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I have hepatitis B but am not on treatment to suppress it.

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I do not have any ongoing serious infections.

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My cancer does not show CAIX when tested.

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I have never been treated with CAIX inhibitors.

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I have HIV with a detectable viral load.

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I have had serious heart or circulation problems in the last 6 months.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I need extra oxygen or have severe breathing problems that affect my daily activities.

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I haven't had severe stomach issues or major bowel surgery in the last 3 months.

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My brain metastasis is either untreated or not stable for the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary study objectives

Area Under the Concentration-Time Curve from Zero up to Infinity [AUC(0-inf)]

Area Under the Concentration-Time Curve from Zero up to a Definite Time T [AUC(0-T)]

Determine the Recommended Phase II Dose of SLC-0111 in combination with gemcitabine

+10 more

Other study objectives

CAIX Biomarker Values

Tumour Metabolic Response Using Positron Emission Tomography with 18F-FDG-PET

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SLC-0111 + GemcitabineExperimental Treatment2 Interventions

Dose Level 1 - SLC-0111 (500 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15) Dose Level 2 - SLC-0111 (750 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15) Dose Level 3 - SLC-0111 (1000 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine Injection

2014

Completed Phase 3

~100

SLC-0111

2014

Completed Phase 1

~30