Phase 2
N=45
SLM + Axitinib for Clear Cell RCC
Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)
Bottom Line
View on ClinicalTrials.gov: NCT02535533 ↗Enrolled (actual)
45
Serious AEs
46.7%
Results posted
May 2026
Primary outcome: Primary: Incidence of Adverse Events (AE) Per CTCAE 4.03 — 3; 5; 7; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Selenomethionine (SLM) (Drug); Axitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mohammed Milhem
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AE) Per CTCAE 4.03 |
3; 5; 7; 20; 8; 2 | — |
| PRIMARY Pilot Phase - Determine Dose-concentration Relationship and Estimate the Effective Dose of SLM (Informed by Preclinical Data) Using the Continual Reassessment Method (CRM). |
0; 0 | — |
| SECONDARY Overall Response Rate |
15 | — |
| SECONDARY Progression-Free Survival |
14.8 | — |
| SECONDARY Overall Survival |
19.6 | — |
Summary
This phase I trial studies the side effects and best dose of L-selenomethionine when given together with axitinib in treating patients with clear cell renal cell carcinoma that has spread from the primary site (place where it started) to other places in the body and usually cannot be cured or controlled with treatment (advanced metastatic). L-selenomethionine may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving L-selenomethionine together with axitinib may be a better treatment for advanced metastatic clear cell renal cell carcinoma.
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following criteria to be enrolled in this study:
- Histologically and radiologically confirmed advanced metastatic CCRCC in patients who have had at least one prior systemic therapy, which can include axitinib for the dose escalation part. In the expansion and pilot phases, patients with prior axitinib are allowed, as long as the last dose of axitinib was longer than 6 months ago.
- Written and voluntary informed consent.
- At least one Response Evaluation Criteria In Solid Tumors (RECIST)-defined target lesion. *Patient must have documented disease progression.
- 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 150/90 mm Hg with medication.
- Present use or anticipated need for cytochrome P450 (CYP) 3A4-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin).Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months. Subjects with history of deep vein thrombosis or pulmonary embolism, at provider discretion.
- Major surgery within 4 weeks of starting study treatment.
- Known HIV or acquired immunodeficiency syndrome-related disease.
Data sourced from ClinicalTrials.gov (NCT02535533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.