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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced, recurrent, or metastatic, incurable (any number of previous lines of therapy is allowed) histologically or cytologically confirmed: colorectal cancer, gastric cancer, non-small cell lung cancer, HER2- breast cancer, squamous cell carcinoma of the head and neck, urothelial cancer, or select gynecologic cancer (ovarian cancer, cervical cancer, or endometrial cancer)
Adults ≥ 18 years old at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment to 30 days after last dose
Awards & highlights
Study Summary
This trial tests how safe and tolerable a new cancer treatment is for adults with certain types of tumors.
Who is the study for?
Adults over 18 with certain advanced solid tumors and specific genetic changes (PIK3CA mutations/amplifications) can join. They should have a life expectancy of at least 3 months, be able to consent, have measurable disease, good performance status (ECOG 0 or 1), and proper organ function. Excluded are those with diabetes, obesity (BMI ≥30), recent cancer treatments, heart issues within the past six months, prior PI3K pathway inhibitors use (except some breast cancer patients), other recent cancers or active brain metastases.Check my eligibility
What is being tested?
TOS-358 is being tested for safety in adults with select solid tumors. The study will determine the highest dose patients can tolerate when taken orally once or twice daily without severe side effects and establish a recommended dose for future studies.See study design
What are the potential side effects?
While specific side effects of TOS-358 aren't listed here, common ones from drugs targeting the PI3K-AKT-mTOR pathway may include diarrhea, skin rash, fatigue, high blood sugar levels and infections. Side effects often vary based on dosage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be cured, including specific types like colorectal, lung, or breast cancer.
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I am 18 years old or older.
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My cancer has a PIK3CA mutation or amplification.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood, liver, and kidney tests are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to 30 days after last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the rate of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs) and specific laboratory abnormalities graded according to NCI CTCAE v5
Trial Design
1Treatment groups
Experimental Treatment
Group I: TOS-358 Single Agent ArmExperimental Treatment1 Intervention
Multiple doses of TOS-358 for oral administration.
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Who is running the clinical trial?
Totus MedicinesLead Sponsor
Ovid Trifan, MD, PhDStudy DirectorTotus Medicines
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 3 years, except for specific minor cases.I have not taken drugs targeting the PI3K-AKT-mTOR pathway, except if I have breast cancer.I haven't had cancer treatment before starting this trial.I have a history of diabetes.I have not had a recent heart attack or severe heart failure.I can provide a sample of my tumor for PIK3CA mutation testing.I am 18 years old or older.My cancer has a PIK3CA mutation or amplification.I am fully active or restricted in physically strenuous activity but can do light work.My blood, liver, and kidney tests are normal.I have active cancer spread to my brain or spinal cord.I have been diagnosed with Cushing syndrome.My cancer is advanced and cannot be cured, including specific types like colorectal, lung, or breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: TOS-358 Single Agent Arm
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.
Has the administration given its sanction to TOS-358 Single Agent Arm?
"This Phase 1 clinical trial has not accumulated substantial evidence of safety or efficacy, thus it was rated a 1 on our scale."
Answered by AI
What is the limit of volunteers taking part in this experiment?
"Indeed, the clinicaltrials.gov page reflects that this trial is presently seeking participants. This research was initially published on February 15th 2023 and updated most recently on March 10th 2023 with a total of 241 patient enrolment at 1 site."
Answered by AI
Are there still opportunities to partake in this investigation?
"Indeed, the information posted on clinicaltrials.gov attests that this specific medical trial is currently accepting patients. Initially advertised on February 15th 2023, it has been updated most recently in March 10th 2023."
Answered by AI
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