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Small Molecule
SHetA2 for Gynecologic Cancers (Okgyn1 Trial)
Phase 1
Recruiting
Led By Debra Richardson, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 18 years old.
Patients must be able to take oral medications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to three years
Awards & highlights
Okgyn1 Trial Summary
This trial is testing the safety of SHetA2, a potential new cancer treatment, in patients with recurrent cervical, ovarian, or endometrial cancer.
Who is the study for?
This trial is for adults with advanced or recurrent ovarian, cervical, and endometrial cancers resistant to platinum therapy or other treatments. Participants must have good organ function, no severe infections like HIV with a positive viral load, no recent major surgeries, and not be on certain medications that could affect the study results. They should be able to take oral meds and agree to use contraception if applicable.Check my eligibility
What is being tested?
The trial is testing SHetA2's safety and effectiveness in patients with specific types of cancer that have come back after treatment. It involves taking this investigational drug to see both its positive effects (like shrinking tumors) and any negative ones (side effects).See study design
What are the potential side effects?
While the exact side effects of SHetA2 are being studied in this trial, participants will be closely monitored for any adverse reactions due to their medical history of allergies or reactions to similar compounds.
Okgyn1 Trial 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 take pills by mouth.
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My blood, kidney, liver, and nerve functions are within normal ranges.
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I can take care of myself and am up and about more than half of the day.
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My cancer has returned and progressed after all treatments, with documented proof.
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I stopped any cancer-related hormone therapy at least a week ago but may still be on hormone replacement therapy.
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I must get a new biopsy before treatment starts.
Okgyn1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dosage Recommendation for Phase 2
Number of dose-limiting toxicities of treatment with OK-1
Secondary outcome measures
Plasma
Cmax of PK plasma concentration
Incidence of adverse events
+7 moreOkgyn1 Trial Design
1Treatment groups
Experimental Treatment
Group I: OK-1 capsuleExperimental Treatment1 Intervention
OK-1 (oral, BID) within a 21-days cycle
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,563 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,023 Total Patients Enrolled
Debra Richardson, MDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a transplant of an organ, bone marrow, or stem cells.I have not taken steroids or immunosuppressants in the last 7 days.I do not have another cancer that could affect this treatment's safety or results.I am willing to undergo a biopsy after the first treatment cycle.I cannot take medications by mouth.I am currently being treated for an autoimmune disease.I am not pregnant, breastfeeding, and I use effective birth control.I do not have active hepatitis, ongoing infections, or HIV/AIDS with a positive viral load.I can take pills by mouth.I have had a bone marrow or stem cell transplant.I have another cancer, but it won't affect this trial's treatment.I haven't had chemotherapy, targeted therapy in the last 4 weeks, or radiation in the last 2 weeks.I have not been in a clinical study or received study therapy in the last 4 weeks.My blood, kidney, liver, and nerve functions are within normal ranges.I can take care of myself and am up and about more than half of the day.My cancer has returned and progressed after all treatments, with documented proof.I stopped any cancer-related hormone therapy at least a week ago but may still be on hormone replacement therapy.I have no history of significant brain-related health issues in the past 6 months.I must get a new biopsy before treatment starts.I have not had major surgery in the last 28 days.I am not on any other cancer treatments or experimental drugs.
Research Study Groups:
This trial has the following groups:- Group 1: OK-1 capsule
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.
Are additional volunteers being sought for this research endeavor?
"Indeed, according to clinicaltrials.gov the study is actively recruiting participants after being initially posted on June 27th 2022 and recently edited on July 7th 2022. The trial needs 50 volunteers from a single location for completion."
Answered by AI
Has SHetA2 been granted authorization by the Food and Drug Administration?
"The safety of SHetA2 was rated a 1 on the scale due to it being in Phase 1 trials, and thus having sparse evidence regarding its effectiveness and potential side effects."
Answered by AI
How many participants have been recruited for this experiment?
"Affirmative. Clinicaltrials.gov states that this medical trial is recruiting patients, which began on June 27th 2022 and was most recently updated on July 7th 2022. The study requires the recruitment of 50 individuals from a single site to participate in its research operations."
Answered by AI
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