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Tyrosine Kinase Inhibitor
SLM + Axitinib for Kidney Cancer
Phase 1 & 2
Waitlist Available
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal function (creatinine level within normal institutional limit, or creatinine clearance >15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).
Liver function (AST/ALT <2.5 X institutional upper limit of normal OR < 5 x institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat advanced kidney cancer. The first part of the trial will test different doses of the drugs to find a safe dose, and the second part will see if the combination is effective.
Who is the study for?
Adults with advanced metastatic clear cell renal cell carcinoma (CCRCC) who've had at least one systemic therapy can join this trial. They must have a target lesion, adequate organ function, and an ECOG status of 0-2. Pregnant women, recent major surgery patients, those with untreated brain metastases or uncontrolled hypertension are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and early effectiveness of combining axitinib with selenomethionine (SLM) in treating CCRCC. It includes dose escalation/expansion phases and a pilot study to determine effective selenium doses based on body surface area.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cancer medications such as fatigue, nausea, liver function changes, blood pressure variations, and possibly unique side effects from the combination of SLM and axitinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
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My liver tests are within the required range.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My cancer has grown or spread, and it can be measured by scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AE) per CTCAE 4.03
Pilot Phase - Determine dose-concentration relationship and estimate the effective dose of SLM (informed by preclinical data) using the continual reassessment method (CRM).
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)
Tumor Response rate as assessed by RECIST v.1.1
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study TreatmentExperimental Treatment2 Interventions
During the Dose-Escalation Part 1, patients will receive SLM twice daily for 14 days followed by SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert. Treatment will continue until disease progression or unacceptable toxicity.
During the Expansion Part 2, patients will be treated at the maximum tolerated dose (MTD) of SLM determined as 4000 mcg SLM. SLM will be given orally twice daily for 14 days followed by SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert. Treatment will continue until disease progression or unacceptable toxicity.
During the Pilot Phase, dosing will begin at dose level 3 (4000, 5000, or 6000 mcg SLM calculated based on patients' BSA). SLM will be given orally twice daily for 14 days. Each cohort will enroll 2 evaluable patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
FDA approved
Find a Location
Who is running the clinical trial?
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
149 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,827 Total Patients Enrolled
Yousef Zakharia, MDPrincipal Investigator - University of Iowa Hospitals & Clinics
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
4 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is over 150/90 mm Hg, even with medication.I am not using and do not need drugs that affect liver enzymes.I haven't had any other cancers in the last 5 years that could affect this treatment.My kidney function, measured by creatinine levels, is within the normal range.My liver tests are within the required range.I am 18 years old or older.I haven't had a heart attack, severe chest pain, heart failure, or stroke in the last 6 months.I have not had major surgery in the last 4 weeks.I have HIV/AIDS.I have advanced kidney cancer and have had at least one treatment before, but it's been over 6 months since my last axitinib dose.It's been over 2 weeks since my last systemic treatment, or over 4 weeks for specific treatments.I agree to have a biopsy as scheduled, if it's considered safe by my doctors.I am able to care for myself and perform daily activities.My cancer has grown or spread, and it can be measured by scans.Your blood tests show that you have enough white blood cells, platelets, and hemoglobin.I have untreated brain metastases causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this trial still ongoing?
"Affirmative. Clinicaltrials.gov indicates that the clinical trial, which was originally posted on January 1st 2016 and updated most recently on August 19th 2022, is presently recruiting participants from one site. The researchers are looking for 46 patients in total."
Answered by AI
What prior research has been done regarding the efficacy of Axitinib?
"Presently, 48 of Axitinib's clinical trials are ongoing with 4 in their third phase. While Houston houses a few studies on this medication, there are an expansive 1038 sites currently exploring it."
Answered by AI
Is this trial a pioneering venture in its field?
"Investigations into Axitinib began in 2011, with the initial trial sponsored by Pfizer and involving 39 participants. After fulfilling Phase 2 criteria for drug approval, 48 live trials have since been launched across 386 cities and 30 countries."
Answered by AI
What is the current capacity of this research project's participant intake?
"Affirmative. The data provided on clinicaltrials.gov attests that this trial is actively enrolling patients, with the initial posting occuring January 1st 2016 and most recent edits taking place August 19th 2022. A total of 46 test subjects are needed for the single medical centre hosting this experiment."
Answered by AI
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