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NCT03531645 · ClinicalTrials.gov registry record · Phase 2
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
A Phase 2 study of Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03531645: Active Phase 2 study of Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.
NCT03531645 is a Phase 2 study of Malignant Neoplasms of Female Genital Organs that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 40-participant average among 5 other Malignant Neoplasms of Female Genital Organs trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03531645, a Phase 2 study of Malignant Neoplasms of Female Genital Organs, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Abemaciclib
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT03531645 still lists
NCT03531645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 40-participant average among 5 other Malignant Neoplasms of Female Genital Organs trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Malignant Neoplasms of Female Genital Organs appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.
NCT03531645 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03531645 about?
NCT03531645 is a clinical study titled "Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma". 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 ava...
What is the current status of trial NCT03531645?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-08-13. Estimated completion is 2027-09-30.
What conditions does trial NCT03531645 study?
This clinical trial studies the following conditions: Malignant Neoplasms of Female Genital Organs.
What interventions are being tested in trial NCT03531645?
The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT03531645?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03531645 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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