A Phase 1/2 interventional study of Selenomethionine (SLM) and Axitinib in Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC), sponsored by Mohammed Milhem. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Mohammed Milhem · Phase 1/2, Interventional, and Treatment
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.
This is a Phase I trial for safety and preliminary efficacy of the combination of axitinib and SLM for adult patients with advanced metastatic CCRCC. This will be a two part study consisting of a dose escalation and expansion study.
Dose-Escalation Part 1 (6-12 patients): SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity. The MTD was determined to be 4000 mcg SLM.
Expansion Part 2: In this phase (approximately 19 patients), will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
A pilot group of 10 subjects will have SLM dose calculated based on patients' BSA to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 45 is close to the median of 46 across 668 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Mohammed Milhem is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Each patient must meet all of the following criteria to be enrolled in this study:
Adequate hematological lab values including;
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Selenomethionine (SLM) · Drug: Axitinib
SLM administrated 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
Following SLM administrated orally twice daily for 14 days, SLM once daily in combination with Axitinib 5 mg twice daily with titration according to package insert
Maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) 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
Following maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) given orally twice daily for 14 days, SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert
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
Incidence of Adverse Events (AE) Per CTCAE 4.03
The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
Time frame: After 2 cycles (28 days)
Pilot Phase - Determine Dose-concentration Relationship and Estimate the Effective Dose of SLM (Informed by Preclinical Data) Using the Continual Reassessment Method (CRM).
Dose escalation for this pilot study will be conducted using a CRM in which the probability of exceeding a blood selenium concentration of 45 µM on Day 14 is being modeled. Prior probabilities of exceeding a blood selenium concentration of 45 µM on Day 14 were estimated based on preclinical and preliminary data from the initial trial. A one parameter logistic model with intercept set at 3 and an initial value of 1 for the slope will be used to estimate the dose-concentration relationship through sequential recursive Bayesian assessment. The target probability of exceeding 45 µM is ≤20%.
Time frame: 14 days
Overall Response Rate
The overall response rate is the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From treatment initiation to treatment end, up to 3 years
Progression-Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From treatment initiation up to 2 years
Overall Survival
Overall survival is defined as the time from study treatment initiation to death due to any cause. Patients still alive were censored at the last date known to be alive.
Time frame: From treatment initiation up to 3 years
| Milestone | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) |
|---|---|---|---|---|---|---|
| Started | 3 | 5 | 7 | 20 | 8 | 2 |
| Completed | 0 | 0 | 2 | 4 | 2 | 2 |
| Not completed | 3 | 5 | 5 | 16 | 6 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 3 | 1 | 0 |
| Withdrew: Alternative therapy | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Disease progression | 2 | 3 | 5 | 11 | 4 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Other complicating disease | 0 | 1 | 0 | 1 | 0 | 0 |
The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
| Participants | Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg | Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg | Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Dose Level 4 (BSA-adjusted) |
|---|---|---|---|---|---|---|
| Incidence of Adverse Events (AE) Per CTCAE 4.03 | 3 | 5 | 7 | 20 | 8 | 2 |
Dose escalation for this pilot study will be conducted using a CRM in which the probability of exceeding a blood selenium concentration of 45 µM on Day 14 is being modeled. Prior probabilities of exceeding a blood selenium concentration of 45 µM on Day 14 were estimated based on preclinical and preliminary data from the initial trial. A one parameter logistic model with intercept set at 3 and an initial value of 1 for the slope will be used to estimate the dose-concentration relationship through sequential recursive Bayesian assessment. The target probability of exceeding 45 µM is ≤20%.
| Participants | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Dose Level 4 (BSA-adjusted) |
|---|---|---|
| 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 |
The overall response rate is the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | Dose-Escalation / Dose Expansion Part 1 & 2 |
|---|---|
| Overall Response Rate | 15 |
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| months | Dose-Escalation / Dose Expansion Part 1 & 2 |
|---|---|
| Progression-Free Survival | 14.8 (6.0 to 20.7) |
Overall survival is defined as the time from study treatment initiation to death due to any cause. Patients still alive were censored at the last date known to be alive.
| months | Dose-Escalation / Dose Expansion Part 1 & 2 |
|---|---|
| Overall Survival | 19.6 (12.0 to 40.6) |
Collected over All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Phase 1: SLM 2500 | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Period 2: Phase 1: SLM 3000 | 3/5 (60%) | 4/5 (80%) | 5/5 (100%) |
| Period 3: Phase 1: SLM 4000 | 5/7 (71.4%) | 7/7 (100%) | 7/7 (100%) |
| Period 4: Phase 2: SLM 4000 | 16/20 (80%) | 5/20 (25%) | 20/20 (100%) |
| Period 5: Pilot: SLM Dose Level 3 | 5/8 (62.5%) | 4/8 (50%) | 8/8 (100%) |
| Period 6: Pilot: SLM Dose Level 4 | 2/2 (100%) | 0/2 (0%) | 2/2 (100%) |
| Event | Period 1: Phase 1: SLM 2500 | Period 2: Phase 1: SLM 3000 | Period 3: Phase 1: SLM 4000 | Period 4: Phase 2: SLM 4000 | Period 5: Pilot: SLM Dose Level 3 | Period 6: Pilot: SLM Dose Level 4 |
|---|---|---|---|---|---|---|
| Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders | 1/3 | 0/5 | 0/7 | 0/20 | 0/8 | 0/2 |
| DiarrheaGastrointestinal disorders | 0/3 | 0/5 | 0/7 | 0/20 | 2/8 | 0/2 |
| Abdominal painGastrointestinal disorders | 0/3 | 1/5 | 0/7 | 1/20 | 0/8 | 0/2 |
| PainGeneral disorders and administration site conditions | 0/3 | 1/5 | 0/7 | 0/20 | 0/8 | 0/2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 1/5 | 0/7 | 0/20 | 1/8 | 0/2 |
| Ischemia cerebrovascularNervous system disorders | 0/3 | 1/5 | 0/7 | 0/20 | 0/8 | 0/2 |
| Thromboembolic eventVascular disorders | 0/3 | 1/5 | 0/7 | 0/20 | 1/8 | 0/2 |
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 0/3 | 0/5 | 1/7 | 1/20 | 0/8 | 0/2 |
| FatigueGeneral disorders and administration site conditions | 0/3 | 0/5 | 1/7 | 0/20 | 0/8 | 0/2 |
| FeverGeneral disorders and administration site conditions | 0/3 | 0/5 | 1/7 | 0/20 | 0/8 | 0/2 |
| Event | Period 1: Phase 1: SLM 2500 | Period 2: Phase 1: SLM 3000 | Period 3: Phase 1: SLM 4000 | Period 4: Phase 2: SLM 4000 | Period 5: Pilot: SLM Dose Level 3 | Period 6: Pilot: SLM Dose Level 4 |
|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/3 | 2/5 | 6/7 | 10/20 | 5/8 | 2/2 |
| FatigueGeneral disorders and administration site conditions | 3/3 | 3/5 | 6/7 | 17/20 | 6/8 | 2/2 |
| General disorders and administration site conditions - Other, specifyGeneral disorders and administration site conditions | 0/3 | 2/5 | 4/7 | 1/20 | 1/8 | 2/2 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 0/3 | 0/5 | 1/7 | 8/20 | 2/8 | 2/2 |
| PruritusSkin and subcutaneous tissue disorders | 0/3 | 0/5 | 0/7 | 4/20 | 1/8 | 2/2 |
| AnorexiaMetabolism and nutrition disorders | 0/3 | 3/5 | 5/7 | 10/20 | 7/8 | 0/2 |
| HypertensionVascular disorders | 0/3 | 2/5 | 6/7 | 9/20 | 5/8 | 1/2 |
| HeadacheNervous system disorders | 0/3 | 4/5 | 2/7 | 3/20 | 2/8 | 1/2 |
| DiarrheaGastrointestinal disorders | 2/3 | 3/5 | 5/7 | 15/20 | 4/8 | 1/2 |
| VomitingGastrointestinal disorders | 0/3 | 1/5 | 5/7 | 5/20 | 4/8 | 1/2 |
| Age, Categorical(Participants) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 5 | 12 | 6 | 0 | 29 |
| >=65 years | 0 | 2 | 2 | 8 | 2 | 2 | 16 |
| Age, Continuous(years) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 55 (53 to 57) | 64 (55 to 74) | 59 (50 to 72) | 62 (39 to 76) | 58 (40 to 70) | 69 (69 to 70) | 61 (39 to 76) |
| Sex: Female, Male(Participants) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 3 | 3 | 2 | 10 |
| Male | 3 | 4 | 6 | 17 | 5 | 0 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 5 | 7 | 19 | 8 | 2 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 3 | 5 | 7 | 19 | 8 | 2 | 44 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg | Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg | Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg | Pilot Cohort-Dose Level 3 (BSA-adjusted) | Pilot Cohort-Level 4 Dose (BSA-adjusted) | Total |
|---|---|---|---|---|---|---|---|
| United States | 3 | 5 | 7 | 20 | 8 | 2 | 45 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2016 to primary completion in Aug 2023, 91 months.
Results were first posted in May 2026, 2 years 8 months after primary completion.
Of 31 phase 1/2 interventional studies under Kidney Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 61 and three quarters within 91. This study's 91 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Selenomethionine · Axitinib
Mohammed Milhem