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Selinexor Dosing Schedules for Sarcoma
This trial is testing a new drug, selinexor, for people with soft tissue sarcomas who have run out of other treatment options. Selinexor works by trapping proteins that would normally cause cancer cells to die, causing the cancer cells to die or stop growing.
- Soft Tissue Sarcoma
- Peripheral Nerve Sheath Tumor
- Endometrial Sarcoma
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2017 Phase 2 trial • 116 Patients • NCT02025985
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Who is running the clinical trial?
- You have not received any treatment before, but your condition has worsened since being diagnosed.You can swallow pills.You have taken selinexor or another XPO1 inhibitor before.Arm A is looking for patients with certain types of tumors called MPNST, ESS, and LMS.All types of soft tissue sarcomas are allowed for Arm B.You have received other cancer treatments in the past few weeks.You have stomach or bowel problems that could make it hard for your body to absorb Selinexor, or you have severe stomach or bowel issues, or uncontrolled vomiting or diarrhea.You are older than 18 years.Patients must have been diagnosed with advanced or metastatic soft tissue sarcoma through a tissue sample.Your blood must have enough white blood cells, red blood cells, and platelets.If you are taking certain medications to help your blood, you need to stop taking them for at least 2 weeks before the screening tests. But you can continue taking them during the study.The doctor thinks you are very underweight for your height.You are currently taking other cancer medications, either approved or experimental.You have evidence of cancer growth, or you haven't been treated before but your cancer has grown, or you've been newly diagnosed with cancer that has spread.You must have a measurable disease according to the RECIST 1.1 guidelines.You are able to carry out everyday activities without any issues or with only a little restriction.You must wait at least 2 weeks after a red blood cell transfusion and 1 week after a platelet transfusion before the screening tests. However, you can still receive transfusions if your doctor thinks it's necessary during the study.Your liver function tests need to be within a certain range, unless you have a specific condition called Gilbert's syndrome or known liver metastasis.Your kidneys are working well, and a test from the past 28 days shows you have enough creatinine clearance.Patients must have a confirmed diagnosis of advanced or metastatic soft tissue sarcoma.You can receive red blood cell and/or platelet transfusions if your doctor thinks it's necessary during the study.
- Group 1: Metronomic dosing
- Group 2: Split dosing
- 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
Is the enrollment process for this clinical trial open at present?
"Affirmative. The facts on clinicaltrials.gov attest to the fact that this scientific trial, which was initially posted on March 29th 2021, is actively searching for volunteers. A total of 56 participants need to be recruited from 1 location."
Is Metronomic dosing a viable form of treatment with low risk?
"Our team considers the safety of Metronomic dosing to be low, assigning it a score of 1 due to lack data around both efficacy and safety."
Is this a pioneering clinical trial, or have similar studies been conducted before?
"Metronomic dosing has been on the research radar since 2014, when Karyopharm Therapeutics Inc. sponsored an initial trial with 16 participants. Following this first study and Phase 1 approval for their drug, today there are 48 active trials across 28 different nations in 259 cities worldwide."
How many volunteers are participating in this clinical trial?
"Affirmative, clinicaltrials.gov indicates that enrollment is still open for this research study; the initial posting was on March 29th 2021 and it has been updated as recently as April 7th 2022. The trial requires 56 participants to be recruited from 1 medical site."
What effects are investigators expecting from this clinical examination?
"Over a 28-day period, this scientific project aims to assess the occurrence of toxicity and safety associated with Selinexor prescribed on either metronomic (Arm A) or split dosing (Arm B) schedules. Secondary objectives include analyzing Area under the plasma concentration versus time curve (AUC), characterizing toxicity through NCI CTCAE v5.0 measures, and estimating Progression-Free Survival rate using Kaplan-Meier product limit methods. Descriptive statistics will be applied for summarizing results from first 3 patients per dose level regarding AUC analysis, while Serious adverse events as well as any Adverse Events leading"
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