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Cyclin-Dependent Kinase Inhibitor
TAS-116 + Palbociclib for Advanced Breast Cancer
Phase 1
Recruiting
Led By Wafik El-Deiry, MD, PhD, FACP
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed solid tumors such as ER/PR(+), HER2(-) breast cancer, SCLC, soft tissue sarcoma, endometrial cancer, bladder cancer that has progressed on at least one standard therapy or for which there is no standard therapy. (Metastases or recurrences do not need to be histologically confirmed.)
Patients with any treatment-refractory solid tumor that is RB-deficient (9 patient cohort expansion after phase Ib dose de-escalation phase). Examples include SCLC, soft tissue sarcoma, endometrial cancer, bladder cancer. Patients should have no available standard therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, 6 months, and 12 months of treatment
Awards & highlights
Study Summary
This trial studies a new drug combo to treat advanced breast cancer in patients who have not responded to palbociclib alone or have a mutated retinoblastoma gene.
Who is the study for?
This trial is for post-menopausal women or men over 18 with certain advanced cancers, like breast cancer that worsened after palbociclib treatment, or solid tumors lacking the retinoblastoma gene. Participants must have measurable disease, a life expectancy over 60 days, and be able to swallow pills. They should not be pregnant/nursing and must agree to use birth control.Check my eligibility
What is being tested?
The study tests TAS-116 combined with palbociclib on two groups: those with advanced breast cancer previously treated with palbociclib and those whose cancers lack the retinoblastoma gene. It aims to assess safety and effectiveness of this combination therapy.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal issues affecting absorption, significant eye problems due to corneal damage risk, liver complications from previous conditions like hepatitis or alcoholism, severe allergic reactions similar in nature to components of TAS-116 or palbociclib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment or lacks a standard treatment.
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My cancer is resistant to treatment, lacks RB protein, and has no standard therapy left.
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My breast cancer worsened after treatment with palbociclib.
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I can swallow pills and don't have major stomach or bowel issues affecting medicine absorption.
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Any side effects from my previous treatments are mild or back to normal, except for hair loss and mild nerve damage.
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I am not pregnant and not breastfeeding.
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I am fully active or can carry out light work.
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My organs and bone marrow are functioning normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months, 6 months, and 12 months of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, 6 months, and 12 months of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of TAS-116 with palbociclib.
Secondary outcome measures
Response rate
Trial Design
3Treatment groups
Experimental Treatment
Group I: Level 0 Starting Palbociclib with TAS-116Experimental Treatment2 Interventions
Group II: Level -2 Palbociclib with TAS-116Experimental Treatment2 Interventions
Group III: Level -1 Palbociclib with TAS-116Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-116
2017
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,557 Total Patients Enrolled
2 Trials studying Breast Cancer
449 Patients Enrolled for Breast Cancer
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,317 Total Patients Enrolled
8 Trials studying Breast Cancer
739 Patients Enrolled for Breast Cancer
Wafik El-Deiry, MD, PhD, FACPPrincipal InvestigatorBrown University & Lifespan Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was either nonmelanoma skin cancer, cervical carcinoma in situ, or I've been cancer-free for over 3 years.I have no history of brain tumors or untreated symptoms that could be due to brain metastases.My cancer has worsened despite treatment or lacks a standard treatment.I have been treated with an HSP90 inhibitor before.My cancer is resistant to treatment, lacks RB protein, and has no standard therapy left.You must have at least one visible area of cancer that can be measured according to specific guidelines.My breast cancer worsened after treatment with palbociclib.My brain metastases have been treated, are stable, and I've had no symptoms for 4 weeks.I have a moderate to severe autoimmune or blood flow disorder.I have a history of hepatitis C or chronic active hepatitis B.I am a woman who has gone through menopause or had a hysterectomy.You have had a skin reaction to a medication in the past.I am not taking drugs that affect the CYP3A enzyme.I can swallow pills and don't have major stomach or bowel issues affecting medicine absorption.I have a condition that could harm the surface of my eye.Any side effects from my previous treatments are mild or back to normal, except for hair loss and mild nerve damage.I have a major eye problem.I am over 18 years old.I have lost more than 10% of my weight in the last month.I am not currently taking any experimental drugs or cancer treatments.I do not have severe liver disease or long-term hepatitis.I have a history of liver issues not caused by infections.I have a glucose-6-phosphate dehydrogenase deficiency.I have a history of seizures, not including febrile seizures as an infant.You have had porphyria or psoriasis at any point in your life.I have not had major surgery in the last 4 weeks.I am not allergic to medications similar to palbociclib or TAS-116.I agree to use effective birth control during and for 4 months after the study.I am not pregnant and not breastfeeding.I have been diagnosed with HIV.Your vision is worse than 20/40 when measured using the standard eye chart.I do not have any active infections, heart issues, or mental health/social situations that would prevent me from following the study's requirements.I do not have major gut issues like severe colitis, Crohn's, chronic diarrhea, or surgeries affecting food absorption.I have heart problems that affect my daily activities.I am fully active or can carry out light work.My diabetes is not well-managed.I don't have any serious illnesses that could get worse with this study's treatment.I have heart problems that affect my daily activities.I have lung problems or a history of lung inflammation.I haven't had cancer treatments or still have side effects within the last 4 weeks.I have recovered from side effects of previous cancer treatments, except for hair loss.My organs and bone marrow are functioning normally.
Research Study Groups:
This trial has the following groups:- Group 1: Level -2 Palbociclib with TAS-116
- Group 2: Level 0 Starting Palbociclib with TAS-116
- Group 3: Level -1 Palbociclib with TAS-116
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 Level 0 Starting Palbociclib with TAS-116 a secure medicamental option?
"Level 0 Starting Palbociclib with TAS-116 has not been rigorously tested, so it scored a 1 on our safety scale due to the fact that this is still in its Phase 1 trial."
Answered by AI
Is enrollment to this research initiative currently available?
"Reportedly, this clinical trial is not currently seeking participants. It was initially posted on March 1st 2023 and most recently updated on December 16th 2022 - yet 3274 other trials are open for enrollment presently."
Answered by AI
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