Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04498520

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

Phase I Trial of Abexinostat Combined With Palbociclib and Fulvestrant in Patients With Antiestrogen Refractory ER+, HER2- Breast Cancer and Gynecological Metastatic Tumors

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Pamela Munster · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 1. To determine the safety and tolerability of abexinostat tosylate (abexinostat) and palbociclib in combination with fulvestrant. 2. To determine the maximum tolerated dose (MTD) for abexinostat and palbociclib when combined with fulvestrant at standard dose. SECONDARY OBJECTIVES: 1. To describe the pharmacokinetics associated with abexinostat. 2. To describe the efficacy of abexinostat and palbociclib in combination with fulvestrant in patients with antiestrogen refractory estrogen receptor positive (ER+), HER2 negative(-) breast cancer and gynecological metastatic tumors. 3. To assess the clinical benefit rate (CBR) defined as complete response (CR), partial response (PR), and stable disease (SD) at 6 months and progression free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. EXPLORATORY OBJECTIVES: 1. To assess correlations between overall response rate (ORR), CBR at 6 months, and progression free survival (PFS) with genomic aberrations assessed as cell free tumor deoxyribonucleic acid (DNA) and histone acetylation on peripheral blood. 2. To assess correlations between ORR, CBR at 6 months, and PFS endpoints and peripheral blood mononuclear cell (PBMC) histone deacetylase (HDAC) gene expression, PBMC acetylation in vivo and ex vivo. OUTLINE: This is a dose-escalation study of abexinostat and palbociclib. Patients receive abexinostat orally (PO) twice daily (BID) on days 1-4, 8-11, and 15-18, palbociclib PO once daily (QD) on days 1-21, and fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients will be followed for 90 days after completion of treatment or removal from study, or until death, whichever occurs first.

Conditions

Interventions

TypeNameDescription
DRUGAbexinostat TosylateGiven PO
DRUGFulvestrantGiven IM
DRUGPalbociclibGiven PO

Timeline

Start date
2021-03-31
Primary completion
2025-06-30
Completion
2025-06-30
First posted
2020-08-04
Last updated
2021-05-18

Regulatory

Source: ClinicalTrials.gov record NCT04498520. Inclusion in this directory is not an endorsement.