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Chemotherapy
Selinexor + Chemotherapy/Immunotherapy for Advanced Cancer
Phase 1
Waitlist Available
Led By Aung Naing, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients must have failed prior standard curative chemotherapy for their disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years
Awards & highlights
Study Summary
This trial is studying selinexor when given with standard chemotherapy or immunotherapy regimens to treat patients with advanced cancer.
Who is the study for?
This trial is for adults with advanced cancers that have spread and can't be cured or controlled. They should be relatively healthy (ECOG 0-1), able to take oral meds, not pregnant, willing to use contraception, and recovered from recent treatments/surgeries. It's not for those with certain heart issues, infections, gut blockages, brain tumors or a history of severe immune reactions from past immunotherapies.Check my eligibility
What is being tested?
The study tests Selinexor combined with various standard chemo or immunotherapy drugs in patients with advanced cancer. The goal is to find the safest dose of Selinexor that works best alongside these treatments by observing its effects on cancer cell growth.See study design
What are the potential side effects?
Selinexor may cause fatigue, nausea, loss of appetite, blood count changes and other side effects typical of chemotherapy like hair loss and increased risk of infection. Side effects vary based on the combination of drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My previous chemotherapy aimed at curing my disease did not work.
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I can swallow and keep down pills.
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My liver and kidney functions are within normal ranges.
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I have a confirmed cancer diagnosis, not including blood or brain cancer, needing treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Disease control rate (complete response, partial response + stable disease for at least 6 months
Incidence of adverse events
Objective tumor response rate (complete response + partial response)
+2 moreOther outcome measures
Change in weight
Serial mutations in biopsies
Severity of nausea and vomiting
Side 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
15Treatment groups
Experimental Treatment
Group I: Arms N and O (selinexor, nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8, and 15, nivolumab IV over 30 minutes on day 1, and ipilimumab PO QD on day 1. Cycles repeat every 3 weeks for 4 cycles. Starting cycle 5, patients receive selinexor PO on days 1, 8, 15, and 22 and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm P (selinexor, nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8, 15, 22, 29, and 36, nivolumab IV over 30 minutes on days 1, 15, and 29, and ipilimumab PO QD on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Group III: Arm M (selinexor, nivolumabExperimental Treatment2 Interventions
Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Arm L (selinexor, pembrolizumab)Experimental Treatment2 Interventions
Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group V: Arm K (selinexor, olaparib) (ARM CLOSED)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8, 15, and 22 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group VI: Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8 and 15, capecitabine PO twice daily (BID) on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.
Group VII: Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8 and 15 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.
Group VIII: Arm H (selinexor, FOLFIRI) (ARM CLOSED)Experimental Treatment4 Interventions
Patients receive selinexor PO on days 1, 8, 15 and 22, irinotecan hydrochloride IV over 90 minutes, fluorouracil IV continuously over 48 hours and leucovorin calcium IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.
Group IX: Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8, and 15 and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.
Group X: Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.
Group XI: Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 8 cycles depending con cancer type (6 cycles for non-small cell lung cancer, up to 8 cycles for ovarian cancer and other histological malignancies) in the absence of disease progression or unacceptable toxicity. After 6 to 8 cycles, patients can continue single agent selinexor until disease progression.
Group XII: Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)Experimental Treatment3 Interventions
Patients receive selinexor PO on days 1, 8, and 15, doxorubicin IV over 90 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.
Group XIII: Arm C (selinexor, eribulin)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8, and 15 and eribulin IV over 1 hour on days 1 and 8. Combination treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.
Group XIV: Arm B (selinexor, paclitaxel)Experimental Treatment2 Interventions
Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) on days 1-14. Patients then receive selinexor PO on days 1, 3, 8 and 10 and paclitaxel IV over 3 hours on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After 8 cycles of combination treatment, patients can continue single agent selinexor until disease progression.
Group XV: Arm A (selinexor, carboplatin) (ARM CLOSED)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Cyclophosphamide
1995
Completed Phase 3
~3780
Topotecan
2017
Completed Phase 3
~2400
Fluorouracil
2014
Completed Phase 3
~11540
Pembrolizumab
2017
Completed Phase 2
~2010
Oxaliplatin
2011
Completed Phase 4
~2560
Olaparib
2007
Completed Phase 4
~2140
Capecitabine
2013
Completed Phase 3
~3420
Eribulin
2012
Completed Phase 3
~2700
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Doxorubicin
2012
Completed Phase 3
~7940
Nivolumab
2014
Completed Phase 3
~4750
Paclitaxel
2011
Completed Phase 4
~5380
Leucovorin Calcium
2011
Completed Phase 3
~12290
Pemetrexed
2014
Completed Phase 3
~5250
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,560 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,932 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Aung Naing, MDPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,497 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may not have received first-line treatment for my condition but qualify for certain medications.I meet the specific requirements for my treatment group.I am not pregnant, breastfeeding, recently operated on, have heart issues, infections, stomach problems, or taking other cancer treatments.I am fully active or can carry out light work.Your blood needs to have a certain amount of platelets, hemoglobin, and neutrophils.I have recovered from recent cancer treatments with minimal side effects.I don't have an active autoimmune disease, haven't been on long-term steroids, and haven't had severe side effects from previous immunotherapy.My previous chemotherapy aimed at curing my disease did not work.I can swallow and keep down pills.I have recovered from major surgery that happened more than 4 weeks ago.You are expected to live for at least 12 more weeks.My liver and kidney functions are within normal ranges.I have a blockage in my intestines.My cancer affects my brain or spinal cord under specific conditions.I have a confirmed cancer diagnosis, not including blood or brain cancer, needing treatment.Sorry, I need more specific details to help you with that. Can you provide the specific exclusion criteria for the Arm O (nivolumab and ipilimumab) expansion Cohort O-2?Patients must have a way to measure their disease according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)
- Group 2: Arm K (selinexor, olaparib) (ARM CLOSED)
- Group 3: Arm L (selinexor, pembrolizumab)
- Group 4: Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)
- Group 5: Arm C (selinexor, eribulin)
- Group 6: Arm H (selinexor, FOLFIRI) (ARM CLOSED)
- Group 7: Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)
- Group 8: Arm B (selinexor, paclitaxel)
- Group 9: Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)
- Group 10: Arm P (selinexor, nivolumab, ipilimumab)
- Group 11: Arm A (selinexor, carboplatin) (ARM CLOSED)
- Group 12: Arms N and O (selinexor, nivolumab, ipilimumab)
- Group 13: Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)
- Group 14: Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)
- Group 15: Arm M (selinexor, nivolumab
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.
Does Selinexor pose any risk to those who utilize it?
"Our assessment of Selinexor's safety is 1 since this trial is only in Phase 1 and has limited evidence regarding its efficacy and security."
Answered by AI
To what maladies is Selinexor typically employed?
"Selinexor is typically prescribed to treat squamous cell carcinoma and certain diseases, including multiple myeloma. Additionally, the medication can be used as a follow-up treatment for patients who have received platinum-based chemotherapy."
Answered by AI
Are there numerous facilities conducting this clinical trial within the city's limits?
"Currently, the study is inviting 5 different medical centres to participate in recruiting patients. This includes MD Anderson West Houston located in Houston, M D Anderson Cancer Center based out of Conroe and MD Anderson in The Woodlands near League City; there are 2 other sites yet to be disclosed."
Answered by AI
To what capacity is the clinical trial conducting participants?
"Affirmative. Clinicaltrials.gov's datasets demonstrate that the research, which was posted on June 26 of 2015, is actively searching for participants. Five different medical centres need to enroll a total of 390 patients in order to complete this trial successfully."
Answered by AI
Have researchers previously conducted investigations into the efficacy of Selinexor?
"Currently, 4273 clinical trials are actively researching Selinexor with 847 of those in their final stage. Primarily based out of Guangzhou, Guangdong, the scope of these studies extend to over 170 thousand locations around the globe."
Answered by AI
Are there any vacant slots for participants in this experiment?
"Indeed, the clinical trial website confirms that this study is actively recruiting. It was first posted on June 26th 2015 and most recently edited on August 31st 2022. The project requires 390 participants from 5 distinct study sites to be enrolled."
Answered by AI
Is this research setting a precedent in its field?
"Since the Phase 3 trial for Selinexor, sponsored by Alfacell, was conducted in 1997 with 300 participants, a total of 5239 studies have been done across 94 countries and 5278 cities. Currently, 4273 trials are live."
Answered by AI
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