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Selective Inhibitor of Nuclear Export (SINE)
Selinexor for Diffuse Large B-Cell Lymphoma
Phase 2
Recruiting
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2.
Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial response (part 2) until disease progression or death (maximum of 1 year from part 2 randomization)
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain type of lymphoma who have no other treatment options.
Who is the study for?
Adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have tried at least two but no more than five previous treatments, including an anthracycline-based chemotherapy and anti-CD20 immunotherapy. Participants must not be eligible for stem cell transplant, should have measurable disease, adequate organ function, and a life expectancy over three months. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The trial is testing Selinexor (KPT-330), a potential treatment for those with DLBCL that has returned or resisted other treatments. This Phase 2b study will evaluate the drug's effectiveness in patients who lack other beneficial treatment options.See study design
What are the potential side effects?
While specific side effects of Selinexor in this trial context aren't provided here, common ones from prior studies include fatigue, nausea, loss of appetite, weight loss, low blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been previously diagnosed with DLBCL, either as a new condition or transformed from an indolent lymphoma.
Select...
I have had 2 to 5 treatments for my DLBCL.
Select...
My lymphoma can be measured for treatment response.
Select...
My DLBCL cancer has shown signs of getting worse before treatment.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Overall Response Rate (ORR)
Part 2: Overall Response Rate (ORR) Based on Lugano Criteria
Secondary outcome measures
Part 1: Disease Control Rate (DCR)
Part 1: Duration of Response (DOR)
Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
+6 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort B-Endometrial 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 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2: Arm B-Selinexor 60 mgExperimental Treatment1 Intervention
Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).
Group II: Part 2: Arm A-Selinexor 40 mgExperimental Treatment1 Intervention
Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).
Group III: Part 1: Selinexor 60 mgExperimental Treatment1 Intervention
Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).
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?
Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,335 Total Patients Enrolled
Michael Kauffman, MD, PhDStudy DirectorKaryopharm Therapeutics Inc
9 Previous Clinical Trials
1,223 Total Patients Enrolled
Sharon Shacham, PhDStudy DirectorKaryopharm Therapeutics Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been previously diagnosed with DLBCL, either as a new condition or transformed from an indolent lymphoma.I have ongoing complications from a stem cell transplant.I can swallow pills and don't have issues absorbing medication.My cancer has spread to my brain or its coverings.I have lymphoma or cancer affecting my brain or spinal cord.My condition is primary mediastinal large B-cell lymphoma.I still have significant side effects from my last lymphoma treatment.I do not have any severe illnesses that could put me at risk during the trial.I haven't taken strong CYP3A affecting drugs in the week before starting this treatment.My lymphoma is one of several specific types, including DLBCL with MALT, composite, arising from CLL, or high-grade B-cell.I can take care of myself but might not be able to do heavy physical work.I have had 2 to 5 treatments for my DLBCL.My lymphoma can be measured for treatment response.I have an active hepatitis B, hepatitis C, or HIV infection.I have not had major surgery in the last 2 weeks.My DLBCL cancer has shown signs of getting worse before treatment.It's been over 60 days since my last successful DLBCL treatment, or over 14 weeks if my treatment wasn't as successful.I have an active infection of HBV, HCV, or HIV.My body surface area is less than 1.4 square meters.My lymphoma is not a simple case and involves more than one type or has transformed from another disease.I do not have an infection needing IV drugs on the first day of treatment.I am using or agree to use birth control during and for 3 months after treatment.I am not currently institutionalized by order of a court or official agency.My heart condition is unstable.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Selinexor 60 mg
- Group 2: Part 2: Arm A-Selinexor 40 mg
- Group 3: Part 2: Arm B-Selinexor 60 mg
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.
Have any prior experiments been conducted involving Selinexor?
"Presently, there are 48 clinical trials that investigate the effects of Selinexor with 4 in Phase 3. While Bethesda, Maryland is a major centre for these studies, globally there are 922 locations conducting research on this drug."
Answered by AI
Are there any vacancies for individuals to partake in this clinical research?
"Information gleaned from clinicaltrials.gov affirms that this medical trial is currently in search of participants, having been initially posted on November 1st 2014 and updated most recently on August 30th 2022."
Answered by AI
Is this clinical trial a novel approach to medical research?
"Karyopharm Therapeutics Inc possess 48 ongoing Selinexor studies, hosted across 259 cities and 28 nations. Initially launched in 2014, the drug went through its Phase 1 trial with 16 patients - this has since been followed by 29 further trials."
Answered by AI
Has Selinexor acquired the necessary authorizations for commercial distribution?
"The safety of Selinexor is estimated to be a 2, as this phase 2 trial has generated some evidence that the drug can safely be administered but there is no proof yet it's effectiveness."
Answered by AI
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