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Alkylating agents
Decitabine + Selinexor for Ovarian Cancer
Phase 2
Recruiting
Led By Patrick L Stiff, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be greater than or equal to 18 years of age
Participants must be able to swallow and retain oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test the four-drug combination to learn if it is safe & effective for patients with relapsed ovarian, fallopian or primary peritoneal cancer.
Who is the study for?
This trial is for adults with relapsed ovarian, fallopian tube, or primary peritoneal carcinoma who can take oral meds and have measurable disease. They must have had platinum and taxane treatments before but now show disease progression. Stable CNS metastases treated by radiotherapy are okay; active Hep B is allowed if on antivirals for 8+ weeks.Check my eligibility
What is being tested?
The study tests a four-drug combo (decitabine, selinexor, carboplatin, paclitaxel) to see if it can prevent drug resistance in ovarian cancer chemotherapy. Decitabine and selinexor may help extend remission when combined with standard chemo drugs carboplatin and paclitaxel.See study design
What are the potential side effects?
Possible side effects include reactions typical of chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver or kidney function issues, and potential allergic reactions to the medication components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can swallow and keep down pills.
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My kidneys are working well.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer did not respond or came back after treatment with platinum and taxane.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
40 participants evaluated for safety with treatment-related adverse events and grading using CTCAE 4.3.
Secondary outcome measures
40 participants evaluated for tolerability with treatment-related adverse events and grading using CTCAE 4.3.
40 participants evaluated to determine the cellular immune effects of this combination. B and T cell numbers and subsets after therapy.
40 participants evaluated to determine the clinical efficacy of this novel regimen in both platinum sensitive and resistant recurrent disease as measured by response rates. Response rates (partial response [PR] and complete response [CR])
Trial Design
1Treatment groups
Experimental Treatment
Group I: Decitabine / Selinexor/ Carboplatin / PaclitaxelExperimental Treatment4 Interventions
C1:
Days 1-5: Decitabine 10 mg/m2 IV daily Day 6: carboplatin AUC 5 and paclitaxel 80 mg/ m2 Days 13, 20, and 27: paclitaxel 80 mg/m2 For a single 28 day cycle
Assess Response toxicities and immune effector cell changes
C2-C6:
Days 1-5: Decitabine 10 mg/m2 IV daily Day 6: carboplatin AUC 5 and paclitaxel 80 mg/ m2 Day 7 and weekly thereafter (day 14, 21, 28, 35…) Selinexor 60 mg PO Days 13, 20, and 27: paclitaxel 80 mg/m2 each given x five 28 day cycles
Assess responses by exam, CT scan and blood tests, assess toxicities, and immune effector cell changes as well as progression and overall survival
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,894 Total Patients Enrolled
4 Trials studying Ovarian Cancer
70 Patients Enrolled for Ovarian Cancer
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,539 Total Patients Enrolled
Patrick L Stiff, MDPrincipal InvestigatorLoyola University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic or sensitive to platinum or taxane treatments.I am 18 years old or older.I can swallow and keep down pills.My liver is functioning well.I have never taken Selinexor or similar medications.My kidneys are working well.I do not need ongoing blood thinners for a clot related to my cancer.Participants must have a detectable disease according to specific criteria for gynecologic cancer.I have active Hep B but have been on antiviral therapy for over 8 weeks.I do not have any ongoing infections that aren't being treated.I can take care of myself but might not be able to do heavy physical work.My cancer did not respond or came back after treatment with platinum and taxane.My heart condition is stable.My brain metastases have been stable for 2+ months after radiotherapy.I have not had chemotherapy or radiation therapy before.I do not have untreated brain metastases.I do not have any uncontrolled health conditions like high blood pressure or diabetes.I have not had a heart attack in the last 3 months.I have relapsed or progressing ovarian, fallopian tube, or peritoneal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Decitabine / Selinexor/ Carboplatin / Paclitaxel
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 the FDA authorized Decitabine / Selinexor/ Carboplatin / Paclitaxel?
"Our team at Power judged Decitabine / Selinexor/ Carboplatin / Paclitaxel to be scored 2 on a scale of 1-3 due to the lack of clinical evidence for efficacy, though there is some data confirming its safety."
Answered by AI
Are there any existing openings for prospective participants in this trial?
"Clinicaltrials.gov currently lists this medical trial as inactive, with initial registration on August 28th 2023 and the most recent update dated for August 1st 2023. Unfortunately, it is not open for enrollment at this point in time; however, 688 other trials are presently looking to attract participants."
Answered by AI
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