Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

Summary

This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer. Abexinostat may prevent tumor cells from growing and multiplying and may kill tumor cells. Palbociclib may prevent or slow the growth of tumor cells when used with other anti-hormonal therapy. Estrogen can cause the growth of breast and gynecologic tumor cells. Fulvestrant may help fight breast or gynecologic cancer by blocking the use of estrogen by the tumor cells. Giving abexinostat, palbociclib, and fulvestrant may work better in treating patients with breast or gynecologic cancer.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Hormone Receptor Positive Breast Carcinoma
• Locally Advanced Breast Carcinoma
• Metastatic Breast Carcinoma
• Metastatic Endometrioid Adenocarcinoma
• Metastatic Fallopian Tube Carcinoma
• Metastatic HER2 Negative Breast Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Ovarian Carcinoma
• Metastatic Primary Peritoneal Carcinoma
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Refractory Breast Carcinoma
• Stage IV Fallopian Tube Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Primary Peritoneal Cancer AJCC v8
• Stage IV Uterine Corpus Cancer AJCC v8
• Stage IVA Fallopian Tube Cancer AJCC v8
• Stage IVA Ovarian Cancer AJCC v8
• Stage IVA Primary Peritoneal Cancer AJCC v8
• Stage IVA Uterine Corpus Cancer AJCC v8
• Stage IVB Fallopian Tube Cancer AJCC v8
• Stage IVB Ovarian Cancer AJCC v8
• Stage IVB Primary Peritoneal Cancer AJCC v8
• Stage IVB Uterine Corpus Cancer AJCC v8

Interventions

DRUG

Abexinostat Tosylate

Given PO

DRUG

Fulvestrant

Given IM

DRUG

Palbociclib

Given PO

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Xynomic Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Pamela Munster

  lead OTHER

Principal Investigators

• Pamela N Munster, MD · University of California, San Francisco

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-31

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes