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Unesbulin for Ovarian Cancer (PTC-001 Trial)
Phase 1
Waitlist Available
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented epithelial ovarian, primary peritoneal or fallopian tube carcinoma or high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.)
Newly diagnosed and previously untreated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
PTC-001 Trial Summary
This trial is testing a new cancer drug to see if it is safe and works well with other cancer treatments.
Who is the study for?
This trial is for women with certain types of ovarian, fallopian tube, or primary peritoneal cancer that haven't been treated yet. They should have good bone marrow, kidney and liver function, minimal neuropathy, no serious infections or illnesses recently, not be on hormonal cancer therapy (except hormone replacement), and must use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests Unesbulin's safety and how the body processes it when taken as a capsule or tablet alongside standard chemotherapy in women with specific cancers. It's an early-phase trial where everyone gets the drug to find the best dose and see how well it works.See study design
What are the potential side effects?
While specific side effects of Unesbulin are not listed here, common ones from similar treatments include nausea, fatigue, risk of infection due to low blood cell counts, nerve damage causing numbness or tingling sensations (neuropathy), and possible allergic reactions.
PTC-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.
Select...
I have a new diagnosis and haven't received any treatment yet.
Select...
I stopped any cancer-related hormonal treatments a week ago, but I am still on hormone replacement therapy.
Select...
My nerve damage symptoms are mild or not present.
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I can take care of myself but may not be able to do heavy physical work.
PTC-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose and dose limiting toxicities
Number of patients able to tolerate drug combination
Phase 2 Dose
Secondary outcome measures
Evaluate clinical response
Evaluate pharmacokinetic Area Under the Curve (AUC)
Evaluate pharmacokinetic Maximum Concentration observed (Cmax)
+3 morePTC-001 Trial Design
1Treatment groups
Experimental Treatment
Group I: Carboplatin/Paclitaxel + PTC596Experimental Treatment1 Intervention
Carboplatin AUC 6mg/L IV on day 1; Paclitaxel 175mg/m2 IV on day 1; Unesbulin PO, twice a week, on day 1, 4, 8, 11, 15 and 18 per 21-day cycle for the first 3 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unesbulin
2019
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,583 Total Patients Enrolled
2 Trials studying Ovarian Cancer
102 Patients Enrolled for Ovarian Cancer
PTC TherapeuticsIndustry Sponsor
74 Previous Clinical Trials
6,203 Total Patients Enrolled
Kathleen Moore, MDStudy ChairUniversity of Oklahoma
8 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take medication that weakens my immune system for reasons other than cancer treatment.You have had allergic reactions to drugs similar to Unesbulin or other drugs used in this study.I haven't had cancer, except for non-dangerous skin cancer or certain types within the last 3 years.I had radiation in my abdomen or pelvis, or had it for breast, head, neck, or skin cancer over 3 years ago with no recurrence.I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.I have a new diagnosis and haven't received any treatment yet.My bone marrow, kidneys, and liver are working well.I stopped any cancer-related hormonal treatments a week ago, but I am still on hormone replacement therapy.I have not had a stroke, brain tumor, uncontrolled seizures, or brain bleeding in the last 6 months.I had chemotherapy for an abdominal or pelvic tumor, or for breast cancer over 3 years ago with no recurrence.I haven't needed strong antibiotics or had a serious illness in the last 4 weeks.I have previously been treated with Unesbulin or standard chemotherapy drugs.My nerve damage symptoms are mild or not present.I have not had major surgery in the last 28 days.I have a history of serious lung problems.I have had a bone marrow or stem cell transplant.I am not currently on any other cancer treatments or experimental drugs.I do not have active hepatitis, ongoing infections, or HIV/AIDS.I can take care of myself but may not be able to do heavy physical work.I am currently being treated for an autoimmune disease like lupus or rheumatoid arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin/Paclitaxel + PTC596
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.
How can I join this research endeavor?
"This clinical trial is recruiting 27 people aged 18 to 99 years with a diagnosed carcinoma of the ovaries, peritoneal or fallopian tubes. Eligible candidates should fulfill all these requirements: histologically proven epithelial ovarian cancer (or high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma and mixed epithelial carcinomas), adequate bone marrow function, renal functioning and liver health; no active infection requiring systemic antibiotics nor an uncontrolled medical condition in four weeks prior to enrolment; discontinued hormonal therapies targeted at tumour"
Answered by AI
Is the age criteria for this clinical research restricted to participants over 60?
"This research program is exclusively for individuals aged 18-99. For minors and seniors, there exists 24 studies and 662 trials respectively."
Answered by AI
Are there new openings for participation in this research endeavor?
"The clinicaltrials.gov database indicates that this research is not presently enrolling participants. This investigation was first posted on August 28th 2017, and last updated February 21st 2022; however, 677 other trials are enlisting patients in the present moment."
Answered by AI
What primary aim is this trial attempting to accomplish?
"This 3-year trial seeks to assess the number of patients able to tolerate this drug combination. Additionally, pharmacokinetic metrics such as Cmax and AUC are being measured alongside secondary outcomes like progression free survival."
Answered by AI
What level of risk are patients exposed to when using PTC596?
"With limited supporting data on efficacy and safety, PTC596 is rated as a 1 on our scale from 1 to 3."
Answered by AI
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