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Female Urogenital Diseases and Pregnancy Complications

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Genital Diseases

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All Drugs and Chemicals

Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

Palbociclib Oral Product

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

TAS-116

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

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

Brown University Oncology Research Group

Wafik El-Deiry, MD, PhD, FACP

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".

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

Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined With Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors With Retinoblastoma Deficiency

Dose Limiting Toxicities (DLTs) will include grade 4 neutropenia lasting longer than 7 days, neutropenic fever, grade 4 thrombocytopenia or any Grade 3 non-hematologic toxicity not controlled with medical management.

Complete response (CR), partial response (PR), stable disease (SD) at RP2D will be estimated according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1)

Brown University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer	NCT05655598	Advanced Breast... Treatment-Refra... Retinoblastoma ... SCLC Soft Tissue Sar... Endometrial Can... Bladder Cancer	Palbociclib Ora... TAS-116 TAS-116 TAS-116	18 Years -	Brown University
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer	NCT05655598	Advanced Breast... Treatment-Refra... Retinoblastoma ... SCLC Soft Tissue Sar... Endometrial Can... Bladder Cancer	Palbociclib Ora... TAS-116 TAS-116 TAS-116	18 Years -	Brown University

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