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Protein Kinase Inhibitor
MELK Inhibitor OTS167PO for Breast Cancer
Phase 1
Recruiting
Research Sponsored by OncoTherapy Science, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during cycle1 after the first administration
Awards & highlights
Study Summary
This trial is testing a new drug to see what the maximum tolerated dose is for patients with relapsed or refractory breast cancer.
Who is the study for?
This trial is for women over 18 with advanced or metastatic breast cancer that's unresponsive to standard treatments. They must have a life expectancy of at least 3 months, agree to use contraception, and be able to consent. Excluded are pregnant/lactating women, those with serious infections or other health issues that could affect safety, and anyone who has had certain treatments recently.Check my eligibility
What is being tested?
The study tests the maximum tolerated dose of OTS167PO, an oral capsule treatment for patients with relapsed/refractory breast cancer. It aims to find the highest dose patients can take without severe side effects by gradually increasing amounts under close supervision.See study design
What are the potential side effects?
While specific side effects of OTS167PO aren't listed here, common ones in trials like this may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems. The severity will help determine the maximum tolerated dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed through surgery due to health reasons or because the tumor can't be surgically removed.
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I am fully active or can carry out light work.
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My breast cancer is confirmed and has spread or is advanced.
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My cancer is low in estrogen and progesterone receptors, and not HER2 positive.
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My cancer came back or didn't respond to 1st or 2nd treatments, including specific drugs for TNBC.
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My cancer has returned or didn’t respond to treatment, and there’s no standard treatment available.
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My cancer can be measured and biopsied easily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during cycle1 after the first administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during cycle1 after the first administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD
Trial Design
1Treatment groups
Experimental Treatment
Group I: OTS167POExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
OncoTherapy Science, Inc.Lead Sponsor
6 Previous Clinical Trials
147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain tumor that originated in my brain.My side effects from previous cancer treatments are mild, except for possible stable nerve pain.Patients must have a way to measure their disease using specific guidelines for triple-negative breast cancer.Your blood tests show low levels of white blood cells, platelets, or hemoglobin.I am able to follow the study's requirements.My cancer cannot be removed through surgery due to health reasons or because the tumor can't be surgically removed.You have a disease that can be measured or evaluated using specific criteria called RECIST v1.1.I am fully active or can carry out light work.I haven't had cancer treatment with drugs or antibodies in the last 2 weeks.You have a history of HIV, or currently have an active hepatitis B or C infection.You have tumors that cannot be safely reached for a biopsy.My brain metastases are not controlled or need treatment.My blood tests show liver or kidney function outside the normal range.I need surgery for my cancer, whether it's where it started or where it has spread.I haven't had extensive radiotherapy in the last 4 weeks or targeted radiotherapy for symptom relief in the last week.I haven't taken any hormonal therapy not for breast cancer within the last week.I do not have a serious infection or fever over 38ºC in the last week.I am not pregnant, breastfeeding, and if I can have children, I use effective birth control.I have fully recovered from any past surgeries and haven't had major surgery in the last 4 weeks.I do not have any severe illnesses or organ problems that could affect my safety in the study.My breast cancer is confirmed and has spread or is advanced.My cancer is low in estrogen and progesterone receptors, and not HER2 positive.My cancer came back or didn't respond to 1st or 2nd treatments, including specific drugs for TNBC.I have not taken any herbal supplements in the week before starting the study drug.I am a woman aged 18 or older.My cancer has returned or didn’t respond to treatment, and there’s no standard treatment available.You are expected to live for at least 3 months.I have a serious heart condition.You are allergic to any parts of OTS167.My cancer can be measured and biopsied easily.I have a blood cancer such as leukemia, lymphoma, or multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: OTS167PO
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.
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