CLINICAL TRIAL

Abemaciclib for Carcinoma, Renal Cell

Waitlist Available · 18+ · All Sexes · Hershey, PA

This study is evaluating whether a combination of two drugs may help treat advanced renal cell carcinoma.

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About the trial for Carcinoma, Renal Cell

Eligible Conditions
Carcinoma · Metastatic Renal Cell Carcinoma ( mRCC) · Carcinoma, Renal Cell

Treatment Groups

This trial involves 2 different treatments. Abemaciclib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Sunitinib
DRUG
Abemaciclib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
FDA approved
Abemaciclib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Has evidence of metastatic disease. Intermediate and poor risk patients according to International Metastatic Renal Cell Carcinoma Database criteria (IMDC) must have received prior combination ipilimumab and nivolumab therapy and subsequently experienced disease progression, or been offered ipilimumab and nivolumab combination therapy and refused, or be ineligible for combination ipilimumab and nivolumab therapy. Patients with favorable risk disease have no eligibility requirement for prior use of ipilimumab and nivolumab immunotherapy.
Intermediate and poor risk patients (according to IMDC criteria) must also have received prior cabozantinib therapy and subsequently experienced disease progression, or been offered cabozantinib therapy and refused, or be ineligible for cabozantinib therapy. Patients with favorable risk disease have no eligibility requirement for prior use of cabozantinib. Cytoreductive nephrectomy is allowed but not mandatory.
Has in the opinion of the investigator, a predicted life expectancy of more than 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2.
Patients with central nervous system metastases must have received surgical and/or radiation treatment, the metastases must be neurologically stable, and patients must be off corticosteroids or receiving a stable low-dose regimen of corticosteroids (i.e., a daily dose of 10 mg or less of prednisone or equivalent) for at least 4 weeks prior to the first dose of study drug.
Has completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy, at least 3-4 weeks from prior VEGFR/mTOR/ or immunotherapy or any other tyrosine kinase inhibitor (TKI) therapy, and at least 4 weeks for treatment with investigational drugs
Has either archival tissue for analysis or will require confirmation of disease with fresh biopsy. Tissue will not be required pre/post treatment for biomarker analysis.
Must be able to swallow capsules and tablets.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Abemaciclib will improve 3 primary outcomes and 6 secondary outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of 44 days after the last dose of study drug.

Continued Toxicity assessment of the maximum tolerated dose (i.e the recommended Phase II dose) of Abemaciclib and Sunitinib as determined from the from dose escalation phase.
44 DAYS AFTER THE LAST DOSE OF STUDY DRUG
Continued safety assessment of the combination of Abemaciclib and Sunitinib when administered at the maximal tolerated dose (i.e. the recommended phase 2 dose)
Disease Control Rate
54 WEEKS
The number of subjects achieving a response (complete response, partial response, stable disease) on the combination regimen of Abemaciclib and Sunitinib at 6, 12, 24, 36, 45, and 54 weeks post initiation of treatment.
Maximum tolerated dose (MTD)
AT THE END OF CYCLE 1 (EACH CYCLE IS 21 DAYS)
A standard 3+3 trial design will be used to determine the safest maximal tolerated dose of the combination of Abemaciclib with Sunitinib. Doses of each medication will be increased or decreased based on upon tolerability and assessment of any dose limiting toxicity(ies) that may occur in study subjects. Safety and toxicity will be evaluated using the NCI Common Toxicity Criteria.
Pharmacokinetic Assessment of Abemaciclib and Sunitinib trough levels at steady state
DAYS 8, 15, 21, 28, 35, 42, 56, 63, 77, 84, 98 (AT THE BEGINNING AND WEEKLY DURING CYCLES 1 AND 2, DAYS 1 AND 15 OF CYCLES 3-5; A CYCLE IS 21-DAYS)
Assessment of steady state trough levels of Abemaciclib and Sunitinib
Progression Free Survival
3 YEARS
The duration of time from the date of start of treatment until the criteria for disease progression is met by RECIST v1.1 criteria.
Median Progression Free Survival
3 YEARS
The median number of days of progression free survival from initiation of Abemaciclib and Sunitinib to completion of the protocol prescribed drug regimen and required follow up time period.
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Patient Q & A Section

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

What are the signs of carcinoma, renal cell?

There are a range of features that are common to carcinoma, renal cell. These include fatigue, weight loss, fever, painful urination and dark urine. Other signs of renal cell carcinoma include: blood in the urine, bleeding from the surface of the body and an abdominal lump. Other signs of carcinoma, renal cell include: abnormal colouring of the skin or nails, unexplained bleeding or bruising, feeling tired and weakness. If these features are present, you should contact your specialist as soon as possible and arrange for a medical examination. summary: This article covers the symptoms of various types of cancers.

Anonymous Patient Answer

What are common treatments for carcinoma, renal cell?

The most common therapy for RCC (renal cell carcinoma) is adjuvant chemotherapy, specifically with vincristine, paclitaxel, oxaliplatin, and bevacizumab; this approach has been shown to increase the survival of patients with stage II tumours. Chemotherapy, alone and with immunotherapy, is the most commonly used treatment for patients with stage III and stage IV renal cell carcinoma. Immunotherapy with vascular endothelial growth factor-A1 inhibitor or checkpoint inhibitors is proving effective and the data imply that it is preferable to chemotherapeutic approaches in the early stages of the disease.

Anonymous Patient Answer

Can carcinoma, renal cell be cured?

Tumor cell death is possible in carcinoma, renal cell, treated by chemotherapy with a high response rate, if there is no significant damage to normal tissue. However, the tumor cells that survive must undergo clonal expansion or go on to form a new tumor. In such cases, chemotherapy, alone or in combination with surgery, has no curative effect. Thus, tumors, renal cell cannot be cured.

Anonymous Patient Answer

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

Around 1 million Americans are diagnosed with carcinoma, renal cell the most common, each year. Most of these (80% or more) live in western and eastern United States. The median age at diagnosis of carcinom is 70 years. The median survival is 8 months with <0.04% of the 5-year survivors being living more than 5 years. Patients with distant-stage renal carcinoma are at a high risk of death, with survival half that of patients with localized disease.

Anonymous Patient Answer

What causes carcinoma, renal cell?

The risk factors for renal cell carcinoma in young persons who have no family history and who are not obese are still unknown. A study of these subjects is warranted to identify their risk factors. Although renal cell carcinoma tends to be diagnosed late because of the advanced-stage prognosis, early screening may be beneficial.

Anonymous Patient Answer

What is carcinoma, renal cell?

CCRCC is the most common form of renal cell cancer and is typically found in men over the age of 50. Treatment depends on the specific type of cancer that has occurred within the kidney. CCRCC is diagnosed almost always after a lengthy period of time from the start of the complaint or presentation of signs and symptoms, usually between the ages of 60 and 70. By and large, this occurs after a long period of time of chronic nephritis.

Anonymous Patient Answer

What is the average age someone gets carcinoma, renal cell?

The average person getting first diagnosis of carcinoma is 62 years of age. The age at diagnosis for renal cell cancer is 61 yr. The most frequent form of cancer is carcinoma (14.7,5%) in the whole male series, but in the females carcinoma made up 21/26 (88%) of all the patients. Renal cancer is more common in women of 60 yr than in men of age 40 yr and over.

Anonymous Patient Answer

Is abemaciclib typically used in combination with any other treatments?

Abemaciclib is a well-tolerated agent approved for use in combination with either capecitabine (trade name Xofigo; XLIS Pharmaceuticals, Indianapolis, IN) or in combination with letrozole (Femara), the drug it was most commonly used with (Femara).

Anonymous Patient Answer

Is abemaciclib safe for people?

In general, BID is well tolerated in patients with advanced solid cancer with previously progressing tumors. Abemaciclib is associated with a favorable safety profile as compared with placebo (n=564).

Anonymous Patient Answer

How serious can carcinoma, renal cell be?

A wide variety of tumours of kidney (except renal clear cell tumours) can become a life threatening condition. Nephrectomy for malignant tumours [renal cell carcinoma, metastases to the kidney, etc] is not surprising. On the other hand, other kidney lesions can be a source of worry to an oncologist. Here, we will only focus on renal cell carcinoma. Although cancer of kidney rarely causes high mortality rate, it can be a constant source of worry to some patients.

Anonymous Patient Answer

What are the latest developments in abemaciclib for therapeutic use?

The development of abemaciclib and its combination therapies is a long process, as patients and physicians need to anticipate the potential clinical benefits of the drug and also have the necessary time to understand the clinical and safety profiles of these drugs. To date, this is an active area of research, with many new compounds in the testing phase and progressing towards clinical evaluation, especially in hormone receptor-negative settings.

Anonymous Patient Answer

What is the primary cause of carcinoma, renal cell?

Data from a recent study of this study indicate that the most common renal tumor is tubular in origin. Primary renal cell carcinoma is responsible for 50% of nephrectomies performed for renal tumors.

Anonymous Patient Answer
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