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TAS0612 for Advanced or Metastatic Cancer
Phase 1
Recruiting
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through measured progressive disease (estimated up to 24 months)
Awards & highlights
Study Summary
This trial will test the safety of TAS0612 in people with cancer that has spread or returned.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, excluding brain tumors. Participants must have good organ function and a performance status of 0 or 1 on the ECOG scale. Specific cohorts include those with certain genetic mutations like PTEN loss, KRAS G12D/C mutation, NF1 mutation in HER2 negative breast cancer, and HR+/HER2 negative breast cancer resistant to standard treatments.Check my eligibility
What is being tested?
The study is testing TAS0612's safety for patients with various types of advanced solid tumors. It includes different phases: dose escalation to find the safe dosage levels and dose expansion to test effectiveness in specific patient groups defined by genetic characteristics of their cancers.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for drugs treating advanced solid tumors may include fatigue, nausea, diarrhea, decreased appetite, skin reactions at the injection site if applicable, blood count changes increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is HR+/HER2- and has worsened after endocrine therapy and CDK4/6 inhibitor treatment.
Select...
My cancer is advanced or has spread but does not originate from the brain.
Select...
I have HER2 negative breast cancer with an NF1 mutation.
Select...
My cancer has a KRAS G12C mutation.
Select...
My cancer has spread beyond its original location but it's not in my brain.
Select...
My cancer has PTEN loss or mutations.
Select...
I am willing and able to undergo a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through measured progressive disease (estimated up to 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through measured progressive disease (estimated up to 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities (DLTs)
rPFS rate
Secondary outcome measures
Disease Control Rate (DCR) per PCWG3/mRECIST1.1
Duration of Response (DOR) per PCWG3/mRECIST1.1
Overall Response Rate (ORR) per PCWG3/mRECIST1.1
+10 moreOther outcome measures
Exploratory correlation of tissue and/or blood markers with tumor efficacy endpoints and/or tumor resistance to TAS0612
Exposure of TAS0612 and selected efficacy and safety measures.
Pharmacokinetics (PK): Metabolites in plasma
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: TAS0612 ExpansionExperimental Treatment1 Intervention
TAS0612 administered orally
Group II: TAS0612 EscalationExperimental Treatment1 Intervention
TAS0612 administered orally
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,484 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I cannot swallow or digest pills.My organs are functioning well.I have a brain tumor that originated in my brain.My cancer is advanced or has spread but does not originate from the brain.My diabetes is not well-managed.My breast cancer is HR+/HER2- and has worsened after endocrine therapy and CDK4/6 inhibitor treatment.I have recovered from all my previous cancer treatments.I have HER2 negative breast cancer with an NF1 mutation.My cancer has a KRAS G12C mutation.You are currently participating in another medical research that is not suitable for this study.I have a serious heart condition.You have a significant health condition alongside the condition being studied.My cancer has spread beyond its original location but it's not in my brain.I have brain metastases that have not been treated.My cancer has PTEN loss or mutations.I am not taking any strong medication that affects liver enzymes.My cancer has a KRAS G12D mutation.I am willing and able to undergo a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: TAS0612 Expansion
- Group 2: TAS0612 Escalation
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.
Solid Tumors Patient Testimony for trial: Trial Name: NCT04586270 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative still recruiting participants?
"Affirmative. According to the information published on clinicaltrials.gov, this study is still recruiting participants and was initially posted in October 2020 with an update made in December 2021. Overall, 242 individuals are being sought from two distinct clinics for enrolment into the trial."
Answered by AI
What are the core aims of this research endeavor?
"This trial's primary outcome of interest, measured over a two year period, is Dose Limiting Toxicities (DLTs). Secondary outcomes are the plasma concentration and half-life of TAS0612 as well as Duration of Response which assesses disease progression or mortality."
Answered by AI
How have the safety assessments for TAS0612 measured up?
"Due to the limited data available, TAS0612 is estimated to have a safety score of 1. This is a Phase 1 trial and there is only minimal evidence supporting its efficacy or safety."
Answered by AI
How many participants are currently accepted in this clinical experiment?
"Yes, clinicaltrials.gov provides proof that this medical trial is currently in search of volunteers. The study's initial posting dates back to October 15th 2020 and was recently updated on December 2nd 2021. 242 individuals are sought from two different locations for the experiment."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
University of Texas MD Anderson Cancer Center
Centre de Lutte Contre le Cancer Gustave Roussy
Tennessee Oncology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I WOULD REALLY LIKE TO SURVIVE THE CANCER AND KEEP ON LIVING. I WOULD REALLY LIKE TO SURVIVE THE CANCER AND KEEP ON LIVING.
PatientReceived 1 prior treatment
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