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

NCT05655598 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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".

Conditions

Interventions

DRUG

Palbociclib Oral Product

125 mg/day (FDA approved dose) or the last tolerated dose before progression for 21 days of a 28-day cycle

DRUG

TAS-116

120 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

DRUG

TAS-116

80 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

DRUG

TAS-116

40 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

Sponsors & Collaborators

  • Brown University

    lead OTHER

Principal Investigators

  • Wafik El-Deiry, MD, PhD, FACP · Brown University & Lifespan Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-08-05
Completion
2024-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05655598 on ClinicalTrials.gov