WithdrawnPhase 1

TAS-116 Plus Palbociclib in Breast and Rb-null Cancer

Stopped: Lack of accrual

United States0Started 2023-09-12

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients: * Patients with advanced breast cancer that has become worse after taking palbociclib alone * Patients with cancers that have an abnormality in a gene called the "retinoblastoma gene".

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 breast cancer whose tumors progressed after prior palbociclib. * 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. * Patients must have at least one area of measurable disease per RECIST Version 1.1 for solid tumors. * Recovered (\< grade 1) from clinically significant effects of any prior surgery, radiotherapy or other anti-neoplastic therapy, except alopecia * Males or females age \>18 years * Life expectancy \> 60 days as documented by treating investigator * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 * Patients must have normal organ and marrow function as defined in detail in the study protocol * Women must not pregnant and not nursing. * Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug (prior to Day 1 of treatment). Both males and females must agree to use effective birth control …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of TAS-116 with palbociclib.

Timeframe: Start of study treatment through 90 days after last treatment.

Trial details

NCT IDNCT05655598

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-05

View on ClinicalTrials.gov More Advanced Breast Cancer trials