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Selective Inhibitor of Nuclear Export (SINE)
Selinexor Dosing Schedules for Sarcoma
Phase 1
Recruiting
Led By Albiruni Razak, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Arm A the acceptable histologies are MPNST, ESS and LMS
For Arm B all STS histologies are eligible
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.
Awards & highlights
No Placebo-Only Group
Study Summary
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.
Eligible Conditions
- Soft Tissue Sarcoma
- Peripheral Nerve Sheath Tumor
- Endometrial Sarcoma
- Leiomyosarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Arm A is looking for patients with certain types of tumors called MPNST, ESS, and LMS.
Select...
All types of soft tissue sarcomas are allowed for Arm B.
Select...
You are older than 18 years.
Select...
Patients must have been diagnosed with advanced or metastatic soft tissue sarcoma through a tissue sample.
Select...
Your blood must have enough white blood cells, red blood cells, and platelets.
Select...
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.
Select...
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.
Select...
You must have a measurable disease according to the RECIST 1.1 guidelines.
Select...
You are able to carry out everyday activities without any issues or with only a little restriction.
Select...
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.
Select...
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.
Select...
Your kidneys are working well, and a test from the past 28 days shows you have enough creatinine clearance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity and safety of Selinexor given on either a metronomic (Arm A) or split dosing (Arm B) schedule: Adverse Events
Recommended phase 2 dose of Selinexor given metronomically
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC) of metronomic Selinexor
Characterization of the toxicity of metronomic Selinexor
Clinical Benefit Rate (CBR) of metronomic Selinexor
+4 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598588%
Nausea
72%
Vomiting
52%
Anaemia
48%
Thrombocytopenia
48%
Fatigue
48%
Decreased Appetite
48%
Weight Decreased
28%
Dizziness
28%
Insomnia
28%
Abdominal Pain
28%
Asthenia
28%
Dysgeusia
28%
Vision Blurred
28%
Constipation
24%
Dyspnoea
24%
Hypokalaemia
24%
Diarrhoea
16%
Hyponatraemia
16%
Urinary Tract Infection
12%
Cough
12%
Pulmonary Embolism
12%
Pyrexia
12%
Oedema Peripheral
12%
Hypomagnesaemia
12%
Anxiety
12%
Stomatitis
12%
Headache
12%
Abdominal Distension
12%
Malaise
8%
Device Occlusion
8%
Cystitis
8%
Laryngitis
8%
Back Pain
8%
Hydronephrosis
8%
Ascites
8%
Ileus
8%
Dehydration
8%
Hyperglycaemia
8%
Pleural Effusion
8%
Face Oedema
8%
Somnolence
8%
Visual Impairment
8%
Muscular Weakness
8%
Agitation
8%
Hypotension
8%
Oedema
8%
Neutropenia
8%
Lung Infection
4%
Confusional State
4%
Alopecia
4%
Vertigo
4%
Hypertension
4%
Vaginal Haemorrhage
4%
Pneumothorax
4%
Embolism
4%
Dry Mouth
4%
Peripheral Sensory Neuropathy
4%
Pneumonia
4%
Arthralgia
4%
Muscle Spasms
4%
Depression
4%
Hallucination
4%
Dysuria
4%
Haematuria
4%
Contusion
4%
Device Related Infection
4%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Split dosingExperimental Treatment1 Intervention
The second arm of the study is an open-label, non randomized, phase 1b study of selinexor in patients with any histological subtype of STS administered orally one day per week, 40mg in the morning, 20mg in the afternoon and 20mg at night as part of a 28 day cycle. Twenty patients will be accrued to this arm.
Group II: Metronomic dosingExperimental Treatment1 Intervention
This Arm is an open-label, non-randomized, phase 1 study of metronomic dosing of selinexor in patients with locally advanced or metastatic MPNST, ESS, LMS. Up to seven dose levels of Selinexor will be investigated.
Patients will undergo 3+3 based dose escalation to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Selinexor.
Escalating doses of selinexor will be given starting with 2.5 mg (taken orally 4 days in a row followed by 3 days break from treatment, repeating this weekly as part of a 28-day cycle). The first dose for the first 2 patients at each dose level will be staggered by 7 days. Minimum number of patients treated in this trial arm is 18 patients, and maximum 36 patients.
Schedule:
Selinexor flat dosing with dose levels (DLs) of 2.5mg (DL1), 5mg (DL2), 7.5mg (DL3), 10mg (DL4), 12.5mg (DL5), 15mg (DL6), 17.5mg (DL7). A DL-1 (1.25 mg) is also incorporated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,432 Previous Clinical Trials
482,797 Total Patients Enrolled
Albiruni Razak, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Metronomic dosing
- Group 2: Split dosing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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"
Answered by AI
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