Belzutifan for Carcinoma, Renal Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan ( Site 1006), Ann Arbor, MI
Carcinoma, Renal Cell+1 More
Belzutifan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called belzutifan is safe and tolerable in people with advanced kidney cancer.

See full description

Eligible Conditions

  • Carcinoma, Renal Cell

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Renal Cell

Study Objectives

This trial is evaluating whether Belzutifan will improve 4 primary outcomes and 3 secondary outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of Up to ~21 days.

Day 21
Area Under the Plasma Concentration Time Curve (AUC) of Belzutifan
Maximum Observed Plasma Concentration (Cmax) of Belzutifan
Minimum Observed Plasma Concentration (Cmin) of Belzutifan
Up to ~21 days
Percentage of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
Up to ~48.5 months
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Percentage of Participants Who Modify or Interrupt Study Treatment Due to an AE
Up to ~49.5 months
Percentage of Participants Who Experience at Least One Adverse Event (AE)

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma, Renal Cell

Trial Design

4 Treatment Groups

Belzutifan 160 mg TID
1 of 4
Belzutifan 160 mg BID
1 of 4
Belzutifan 200 mg TID
1 of 4
Belzutifan 120 mg QD
1 of 4
Experimental Treatment

This trial requires 52 total participants across 4 different treatment groups

This trial involves 4 different treatments. Belzutifan is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Belzutifan 160 mg TID
Drug
Participants will receive belzutifan 160 mg orally three times daily (TID). Treatment will continue until progressive disease or discontinuation.
Belzutifan 160 mg BID
Drug
Participants will receive belzutifan 160 mg orally twice daily (BID). Treatment will continue until progressive disease or discontinuation.
Belzutifan 200 mg TID
Drug
Participants will receive belzutifan 200 mg orally TID. Treatment will continue until progressive disease or discontinuation.
Belzutifan 120 mg QD
Drug
Participants will receive belzutifan 120 mg orally once daily (QD). Treatment will continue until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~49.5 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to ~49.5 months for reporting.

Closest Location

University of Michigan ( Site 1006) - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Renal Cell or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The individual has had advanced ccRCC for which they have received at least one previous systemic treatment. show original
A female participant is eligible to participate if she is not pregnant, breastfeeding, a woman of childbearing potential, or using contraception. show original
Male participants must be abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention. show original
The subject has a clear cell renal cell carcinoma that has spread and is not operable. show original
The patient has adequate organ function. show original

Patient Q&A Section

Can carcinoma, renal cell be cured?

"The long-term survival of an allopurinol-treated patient who developed renal cell carcinoma and survived 5 years without cancer treatment was reported. The current study was retrospective." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, renal cell?

"Both the use of chemotherapy and radiotherapy have a large effect on survival. However chemotherapy appears to offer slightly higher chance of survival in terms of time to relapse, disease progression, and overall survival." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, renal cell?

"The features associated with carcinoma of the kidney vary among tumours, and the presence and nature of these features can affect clinical management recommendations and can be used as a guide to the identification and grading of renal cell carcinomas." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, renal cell?

"Carcinoma, is the commonest form of kidney cancer. It is usually very treatable. It typically begins in the parenchyma of the kidney. The 5 year survival rate is 80%, but for most patients it is only 10-15% with most deaths occurring in the late stages." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, renal cell?

"Although it is unknown what causes carcinoma, renal cell carcinoma occurs as a result of an alteration in the DNA of the cell. This may produce abnormal proteins or cause cells to proliferate beyond their normal level." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, renal cell a year in the United States?

"In 2003, 3.9 million Americans had carcinoma (skin and nonmelanoma), and 1.2 million had renal cell carcinomas. In the 1990s, there appeared to be a stable, albeit low, prevalence of renal cell cancer in the United States. However, trends in carcinoma and renal cell cancer incidence are not clear at this time." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, renal cell?

"There have been several recent studies reporting the potential mechanisms of therapeutic benefit of some botanical compounds to treat renal cell carcinoma. The use of some botanical compounds may be helpful in the treatment of renal cell carcinoma." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, renal cell?

"A study was conducted between 2016 and 2018 to observe the effects of cancer and renal cancer on patients' brain activity. In a recent study, findings determined that the development of cancer and kidney cancer causes different brain responses of different patients. To explain these differences, future treatment options are essential. Although this work will continue, there are some potential treatment options that future research may result in. One treatment option that could potentially be used in conjunction with kidney transplantation for cancer is a kidney transplantation procedure called bilateral kidney transplantation. This procedure can be beneficial for patients with cancer because their existing kidney can be replaced with a new kidney that has been genetically modified to have its own immune system, reducing the possibility of rejection." - Anonymous Online Contributor

Unverified Answer

How does belzutifan work?

"Belzuthan may increase caspase-3 levels and induce apoptosis in kidney cancer cells. The induction by belzuthan of apoptosis may be related to the inhibition of Akt phosphorylation and its activity, as well as to the decreased expression of survivin protein levels in cells. Furthermore, the activity of belzuthan may be increased at low doses. Future research with similar strategies must be pursued to understand cell death induced by belzuthan." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, renal cell?

"The main causes of RCC, based on the results of the present study, were the following. 1. Infection by the parasite (except schistosoms) was the single cause of bladder carcinoma and the second cause of renal carcinoma. 2. Radiation was the single cause of renal carcinoma. 3. A combination of viral and nonviral infection caused renal carcinoma. 4. Tobacco smoking was the single cause of RCC. 5. A history of the following diseases/accidents/factors were the causes of renal carcinoma. Liver cirrhosis caused renal carcinoma. Radiation therapy was the cause of renal carcinoma. An immune complex of viral and nonviral infection caused renal carcinoma." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, renal cell spread?

"Although the mean duration of the disease was 10.5 months, the actual duration was longer, i.e. more than 6 months. The metastases were localised, i.e. renal cell carcinoma. This led to the treatment regimen being a combination of the VD + C and C + P chemotherapy regimens. It also led to a delay in the mean duration of the disease (27 months) in order to wait for the metastases to spread and to provide more effective chemotherapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, renal cell?

"Elderly and non-elderly patients should be considered for clinical trials for renal cell carcinoma. These trials can reduce the long-term health care costs associated with managing this disease and can improve patient survival." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Renal Cell by sharing your contact details with the study coordinator.