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Axitinib for Renal Cell Carcinoma (APART Trial)
APART Trial Summary
This trial will test to see if the combination of these three drugs is safe and effective in slowing the growth of advanced ccRCC in patients who have not received any prior systemic treatment.
- Renal Cell Carcinoma
APART Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT02129647APART Trial Design
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Who is running the clinical trial?
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- You are 18 years old or older.You can swallow pills or tablets.You had a biopsy or surgery to remove a tumor within the past year.You have enough infection-fighting cells in your blood (neutrophils).Your platelet count must be at least 100 billion per liter.You have a medical condition called an autoimmune disease that could get worse if you take a medicine that boosts your immune system. If you have type 1 diabetes, vitiligo, psoriasis, or thyroid conditions that don't need immune system suppression, you may still be eligible.You cannot have had certain treatments for advanced or metastatic RCC, or certain immunotherapeutic agents before. If you had prior treatment for RCC, it must have been over 12 months ago. You also cannot have had certain therapies that target specific pathways in the body.You have advanced or spread out kidney cancer that can't be removed by surgery, and it's the type that has clear cells. If you have sarcomatoid cells, you can still participate.You have had a transplant with donor cells or organs in the past.You have had lung problems in the past that affected your breathing, including a restrictive lung disease, and/or a respiratory condition that was considered significant by your doctor. You also had radiotherapy in your chest area.You have a known allergy to the study drug or its ingredients.You have taken herbal medications like St. John's wort, Kava, and ginseng in the past week before the trial start.You may choose to have extra tumor biopsies taken for research before starting treatment, 2 months after starting treatment, and after finishing treatment.You have a medical condition that can be measured according to the RECIST 1.1 guidelines.You have not received any other cancer treatment since the time your tissue sample was taken for this study. If a tissue block is not available, at least 10 unstained slides must be provided.A sample of your tumor tissue from when you were first diagnosed is needed for the study. If a tissue block is not available, 10-15 slides of unstained tissue will be accepted.You are able to perform daily activities without assistance, and your physical condition is not severely affecting your quality of life.You have smoked a lot of cigarettes in your life, either currently or in the past.You have had any other form of cancer within the past 2 years, except for some low-risk types such as skin cancer or certain early-stage cancers that are not likely to affect your 5-year life expectancy.
- Group 1: Axitinib, Avelumab and Palbociclib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any other investigations regarding the efficacy of Axitinib?
"At this moment, 272 clinical trials are actively researching Axitinib. Of those studies, 28 have advanced to phase 3 of the investigation and can be found in Burgas New jersey as well as 10 other countries."
What is the total enrollment for this research project?
"This research initiative has reached its recruitment quotas and is no longer seeking candidates. It was initially posted on December 1st 2022 and last edited on October 24th, 2022. If you're searching for other clinical trials, there are currently 2584 cancer-related studies looking to enrol new patients as well as 272 Axitinib related investigations which require participants."
What indications is Axitinib most frequently used to address?
"Axitinib is a common drug used to treat Merkel cell carcinoma, as well as other forms of cancer such as breast cancer and malignant neoplasms. It can also be employed in pharmacotherapy regimens."
Has the regulatory body sanctioned Axitinib?
"Our team at Power gave Axitinib a score of 2, as the drug has been tested for safety in Phase 2 trials but there is still no evidence to support its efficacy."
Are there any openings for individuals to participate in this experiment?
"This particular clinical trial, initially posted on December 1st 2022 and last updated October 24th 2022, is not actively recruiting patients. However, there are hundreds of other medical studies that require participants at this time."
Is this research pioneering a new therapeutic approach?
"Currently, 272 ongoing clinical trials for Axitinib are being conducted in 62 countries and 1693 cities. This drug was first tested back in 2011 by Pfizer; a Phase 2 trial including 39 patients which achieved approval status. Since then, 198 more medical experiments have been completed studying this medication's efficacy."
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