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Tyrosine Kinase Inhibitor

MEDI5752 + Axitinib/Lenvatinib for Kidney Cancer

Phase 1
Recruiting
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and marrow function
Strongly recommend nonsterilized male partners of female subjects of childbearing potential use a male condom plus spermicide from screening to 7.6 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up informed consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Awards & highlights

Study Summary

This trial will test a new drug, MEDI5752, in combination with Lenvatinib or Axitinib, to see if it is effective in treating advanced renal cell carcinoma.

Who is the study for?
Adults with advanced renal cell carcinoma who haven't been treated for it yet can join. They need to be in good health overall, have a life expectancy of at least 12 weeks, and tumors that can be measured. Women must not be pregnant and use birth control; men should too. No recent vaccines or major surgeries, no uncontrolled illnesses or high blood pressure, and no history of certain other cancers or immune disorders.Check my eligibility
What is being tested?
The trial is testing MEDI5752 combined with either Lenvatinib or Axitinib on people with kidney cancer to see how well they work together. Participants will receive these medications and their effects will be monitored closely throughout the study period.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, diarrhea, loss of appetite, weight changes, nausea, mouth sores, rash or redness of the skin. There may also be risks related to liver function changes and potential bleeding issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are working well.
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My partner will use a condom and spermicide until 7.6 months after my last dose.
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I can provide at least 5 slides or a tissue block from my tumor.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am not pregnant and will use effective birth control during the study.
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I weigh more than 35 kilograms.
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My advanced kidney cancer has not been treated yet.
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My kidney cancer is confirmed and has clear cell features.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~informed consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
This trial's timeline: 3 weeks for screening, Varies for treatment, and informed consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
Number of subjects experiencing abnormal laboratory evaluations.
+4 more
Secondary outcome measures
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExplorationExperimental Treatment3 Interventions
The Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (~72 patients)
Group II: Dose ExpansionExperimental Treatment3 Interventions
Evaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (~105 patients )
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Axitinib
2020
Completed Phase 2
~3050

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,730 Total Patients Enrolled
AstraZeneca Early OncologyStudy DirectorAstraZeneca

Media Library

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04522323 — Phase 1
Kidney Cancer Research Study Groups: Dose Expansion, Dose Exploration
Kidney Cancer Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT04522323 — Phase 1
Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04522323 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who fits the criteria to be accepted into this trial?

"This medical trial is accepting 70 individuals aged 18 to 101 who currently have advanced renal cell carcinoma (ARCC). Moreover, applicants must meet the following conditions: minimum age of eighteen at screening, body weight greater than 35 kilograms, no history of ARCC treatment in this setting, a measurable lesion according to RECIST v1.1 criteria, life expectancy exceeding 12 weeks and ECOG performance status 0 or 1."

Answered by AI

What further research has been undertaken with MEDI5752?

"As of now, 194 studies are underway concerning MEDI5752. Of these investigations, 36 have moved into Phase 3 trials. This medication is being studied in Iowa City, IA and 5981 other locations worldwide."

Answered by AI

Is this research pioneering any new techniques?

"Currently, 194 live trials of MEDI5752 are active in 1231 cities within 54 nations. The first trial of the drug began a decade ago and was sponsored by Pfizer; it enrolled 39 participants and achieved Phase 2 regulatory clearance. Since then, 132 additional clinical studies have been launched worldwide."

Answered by AI

Is there any availability for enrollment in this scientific experiment?

"This medical study is presently accepting enrolments, with the initial posting on August 5th 2020 and most recent update occurring on November 3rd 2022. Data can be found in full detail at clinicaltrials.gov."

Answered by AI

How many sites are actively coordinating this clinical trial?

"At present, 6 medical sites are participating in this trial; these include Saint Louis, Fort Myers and Cleveland as well as other cities. For the comfort of participants, it is advisable to select a study site that is near their residence."

Answered by AI

What are the prime directives of this investigation?

"This research programme, which is set to be monitored from the point of consent until 90 days post-treatment, aims to analyse the number of adverse side effects and serious adverse events. Secondary objectives include an assessment of MEDI5752's pharmacokinetics (AUC and t1/2), as well as its antitumour activity when combined with lenvatinib via progression free survival (PFS) according to RECIST v1.1 guidelines."

Answered by AI

Has MEDI5752 received clearance from the FDA?

"Our experts gave MEDI5752 a rating of 1 since it is in the initial stages of research and there are limited data points to demonstrate safety or efficacy."

Answered by AI

Does the enrollment window for this clinical trial include individuals aged 25 and above?

"This clinical trial is accepting patients who are of legal adulthood, between 18 and 101 years old."

Answered by AI

What is the cap on participants for this research endeavor?

"Affirmative. Clinicaltrials.gov records show that this research initiative, which was initiated on August 5th 2020, is actively in the process of recruitment. 70 individuals are required across 6 different clinical trial sites."

Answered by AI

What health concerns does MEDI5752 purport to alleviate?

"MEDI5752 is widely prescribed for aplastic anemia but can also be beneficial to those with advanced renal cell carcinoma (ARCC), malignant neoplasms, and more severe forms of thyroid cancer."

Answered by AI
~86 spots leftby Aug 2027