Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
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|ClinicalTrials.gov Identifier: NCT03531645|
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : August 26, 2019
The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied.
This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Female Genital Organs||Drug: Fulvestrant Drug: Abemaciclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2022|
|Experimental: Fulvestrant + Abemaciclib||
Neoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4.
Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle.
Study cycle is 28 days.
Other Name: Faslodex
Neoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle.
Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle.
Study cycle is 28 days.
- Clinical Benefit Rate (CBR) [ Time Frame: 112 days ]Clinical benefit rate determined by partial response (PR), complete response (CR), and stable disease (SD) associated with 4 cycles of neoadjuvant abemaciclib plus fulvestrant in patients with Low Grade Serous Carcinoma (LGSC). CBR assessed using RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531645
|Contact: Ljiljiana Milojevicfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amir A. Jazaeri, MD||M.D. Anderson Cancer Center|