Fulvestrant Plus Palbociclib in Women With Advanced Low Grade Serous Carcinoma
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|ClinicalTrials.gov Identifier: NCT03531645|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2018
Last Update Posted : December 12, 2018
The goal of this clinical research study is to learn if fulvestrant and palbociclib 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 palbociclib 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: Palbociclib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Translation Study of Neoadjuvant Fulvestrant Plus Palbociclib in Women With Advanced Low Grade Serous Carcinoma|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
|Experimental: Fulvestrant + Palbociclib||
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): Palbociclib 125 mg by mouth On Days 1-21 of each cycle.
Adjuvant Treatment (Cycles 5 and beyond): On Days 1-21 of each cycle, you will take Palbociclib 125 mg by mouth on Days 1-21 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 palbociclib 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: Amir A. Jazaeri, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amir A. Jazaeri, MD||M.D. Anderson Cancer Center|