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Akt/ERK Inhibitor
ONC201 + Paclitaxel for Ovarian Cancer
Phase 2
Recruiting
Led By Ira Winer, M.D.
Research Sponsored by Ira Winer
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 (PS) score of 0-1
Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is studying a combination of two drugs, ONC201 and paclitaxel, to see if they are effective in treating ovarian, fallopian tube, or primary peritoneal cancer that has returned or stopped responding to other treatments.
Who is the study for?
This trial is for women with certain types of ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants should have at least one measurable lesion and be in good physical condition (ECOG score 0-1). They must not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function. Those with more than four prior treatments in the resistant setting or a total of seven overall are excluded.Check my eligibility
What is being tested?
The trial is testing ONC201 combined with weekly paclitaxel against these cancers. ONC201 targets specific receptors on cancer cells while paclitaxel stops their growth by various means. The study aims to see if this combination works better than paclitaxel alone for patients who haven't responded well to previous platinum-based therapies.See study design
What are the potential side effects?
Possible side effects include allergic reactions to treatment components, fatigue from chemotherapy drugs like paclitaxel, potential liver or kidney issues due to drug processing demands on these organs, blood disorders resulting from bone marrow suppression by chemotherapy agents, and gastrointestinal symptoms.
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.
Select...
I have been diagnosed with cancer in my ovary, fallopian tube, or the lining of my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLT's) (Part 1)
Incidence of treatment related adverse events (AEs) (Part 1)
Objective response rate (ORR) (Part 2)
+1 moreSecondary outcome measures
CA-125 response rate
Disease clinical response (DCR)
Duration of response (DOR)
+6 moreOther outcome measures
Cytokine profile
NK cell evaluation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment - ONC201 & PaclitaxelExperimental Treatment3 Interventions
Patients receive ONC201 PO on days 1, 8, 15, and 22 and paclitaxel IV over 1 hour on days 2, 9, and 16. Cycles repeat every 28 days in the absence disease progression or unacceptable toxicity. If paclitaxel must be stopped for any reason, patients may continue on ONC201 alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Ira WinerLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Ira Winer, M.D.5.01 ReviewsPrincipal Investigator - Barbara Ann Karmanos Institute
Barbara Ann Karmanos Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery in the last 3 weeks or minor surgery in the last week.I have ovarian cancer and no other active cancers requiring treatment.I do not have a serious infection or medical condition that would prevent me from participating.I haven't taken any trial drugs within the last 21 days or less than 5 half-lives of the drug.I am not on any other cancer treatments while on the study medication.I am not pregnant, not breastfeeding, and if able to bear children, I agree to use contraception during the study.You have at least one specific spot that can be measured according to a certain set of rules.My cancer got worse within 6 months after finishing a platinum-based treatment.I haven't taken drugs or products like grapefruit juice that affect certain liver enzymes recently.My blood, kidney, and liver tests are normal.I am fully active or can carry out light work.My brain metastases are stable and I haven't taken steroids for them in the last 14 days.I finished any palliative radiation therapy over a week ago and have recovered from its immediate side effects.I have had no more than 4 treatments for platinum-resistant cancer and a total of 7 treatments overall.I can provide a tissue sample from my cancer for the study.I have side effects from past treatments, but they are under control with medication, except for hair loss or loss of appetite.I cannot swallow pills.I have been diagnosed with cancer in my ovary, fallopian tube, or the lining of my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment - ONC201 & 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.
What level of hazard is associated with the use of Akt/ERK Inhibitor ONC201?
"Although no efficacy data has been collected, our team at Power assigned Akt/ERK Inhibitor ONC201 a score of 2 based on the safety information gathered during Phase 2 trials."
Answered by AI
Are there any precedential studies that involve the Akt/ERK Inhibitor ONC201?
"Currently, the drug Akt/ERK Inhibitor ONC201 is present in 840 active clinical trials; of which 227 are at a Phase 3 status. While Adelaide, South Australia has an abundance of trial sites for this medication, there are also 45728 other locations around the world that have been approved to conduct research on it."
Answered by AI
Is recruitment for the trial still open to participants?
"According to clinicaltrials.gov, this research is currently enrolling individuals into the study which began on January 21st 2020 with a recent update being made on May 10th 2022."
Answered by AI
What is the primary aim of this investigation?
"This clinical trial is assessing the Incidence of treatment related adverse events (AEs) as its primary outcome, to be measured over a period up to 28 days. Secondary objectives include evaluating HE-4 response rate, Plasma concentrations of ONC201 and Incidence of treatment related AEs with Fisher's exact tests and McNemar's tests respectively."
Answered by AI
How many subjects will be included in the research initiative?
"Affirmative. Clinicaltrials.gov reveals that this clinical study, which was initially posted on January 21st 2020, is actively seeking participants. Approximately 62 individuals need to be enrolled from a single medical facility."
Answered by AI
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