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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Dose Escalation: Any solid tumor with EGFR and/or HER2 aberration
Have histologically confirmed solid cancer that is locally advanced and metastatic and available standard treatment options have been exhausted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and works against cancer in patients who have no other treatment options.
Who is the study for?
This trial is for people with advanced solid tumors like breast cancer, lung cancer, or glioblastoma who have no remaining standard treatment options. Participants must have a certain type of tumor change (EGFR/HER2), measurable disease, good organ function and be in fair physical shape (ECOG PS 0-1). Those with unstable brain metastases, serious heart issues or unresolved effects from past cancer treatments cannot join.Check my eligibility
What is being tested?
The study tests TAS2940's safety and effectiveness on various cancers without available therapies. It's an early-stage trial to see how the body handles the drug (pharmacokinetics/dynamics) and its initial success in shrinking tumors across different patient groups divided by their specific cancer types.See study design
What are the potential side effects?
As this is a first-in-human study for TAS2940, detailed side effects are not yet known but may include typical reactions seen with other cancer drugs such as nausea, fatigue, allergic reactions and potential impacts on blood counts or organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor has EGFR or HER2 changes.
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My cancer is advanced, has spread, and no standard treatments are left.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation:Maximum Tolerated Dose (MTD)
Dose Expansion:Overall Response Rate
Secondary outcome measures
Dose Escalation: Overall Response Rate (ORR)
Dose Escalation:Pharmacokinetic (PK) Profile
Dose Expansion:Disease Control Rate (DCR)
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: TAS2940 Dose EscalationExperimental Treatment1 Intervention
Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.
Group II: Dose Expansion Solid tumorsExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Group III: Dose Expansion Non-small Cell Lung CancerExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Group IV: Dose Expansion GliblastomaExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Group V: Dose Expansion Breast CancerExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
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Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,542 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My solid tumor has EGFR or HER2 changes.My cancer is advanced, has spread, and no standard treatments are left.I am fully active or can carry out light work.My cancer can be measured by specific medical criteria.My condition is recurrent or refractory glioblastoma.I have a serious heart condition.My brain cancer has not remained the same and is getting worse.My organs are functioning well.I am still experiencing side effects from my previous cancer treatment.I have non-small cell lung cancer.I have HER2 positive breast cancer.My cancer has EGFR or HER2 changes and is not listed in other groups.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Breast Cancer
- Group 2: Dose Expansion Gliblastoma
- Group 3: Dose Expansion Solid tumors
- Group 4: TAS2940 Dose Escalation
- Group 5: Dose Expansion Non-small Cell Lung Cancer
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.
Is TAS2940 sanctioned by the FDA?
"Our assessment of TAS2940's safety is a 1 as there are only small-scale studies to validate its efficacy and limited evidence confirming its safety."
Answered by AI
What results are the researchers hoping to accomplish with this clinical trial?
"Over the course of 6 months, this clinical trial will primarily evaluate Maximum Tolerated Dose (MTD) as its primary outcome. Secondary objectives include Duration of Response (DOR), Overall Response Rate (ORR), and Pharmacokinetic Profile in terms of maximum observed plasma concentration, time to reach maximum concentration, area under the Concentration-time curve and half life values."
Answered by AI
How many participants are accepted into this clinical experiment?
"Affirmative. Clinicaltrials.gov displays data that verifies this clinical trial is presently searching for participants and was first posted on September 16th 2021, with its last update occurring February 25th 2022. At two separate sites, 42 patients are required to be enrolled."
Answered by AI
Does this research endeavor still have capacity for new participants?
"According to the latest data available, this clinical trial is still recruiting participants. The investigation was initially posted on September 16th 2021 and most recently updated on February 25th 2022."
Answered by AI
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