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Tyrosine Kinase Inhibitor
SLM + Axitinib for Kidney Cancer
Phase 1
Waitlist Available
Led By Bilal Rahim, MD
Research Sponsored by Bilal G. Rahim
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.)
Must not have
Pre-existing uncontrolled hypertension defined as > 150/90 mm Hg with medication.
Present use or anticipated need for cytochrome P450 (CYP) 3A4-inhibiting, CYP3A4-inducing drugs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 cycles (28 days)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is over 150/90 mm Hg, even with medication.
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I am not using and do not need drugs that affect liver enzymes.
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I have not had major surgery in the last 4 weeks.
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I have HIV/AIDS.
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I have untreated brain metastases causing symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 2 cycles (28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 cycles (28 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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).
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: 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?
Bilal G. RahimLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
115 Total Patients Enrolled
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,241 Total Patients Enrolled
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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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
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