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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~after 2 cycles (28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 cycles (28 days) 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 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

Media Library

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02535533 — Phase 1
Kidney Cancer Research Study Groups: Study Treatment
Kidney Cancer Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT02535533 — Phase 1
Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02535533 — Phase 1
~5 spots leftby Nov 2025