New drug combo shows promise for rare ovarian cancer
NCT ID NCT03531645
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This pilot phase II study tests whether the drugs fulvestrant and abemaciclib can help control low-grade serous ovarian cancer in women with advanced disease. Up to 18 participants will receive the drugs before and after surgery. The goal is to see how many patients achieve a partial response, complete response, or stable disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fulvestrant (Faslodex) and abemaciclib
- What this could lead to
- If it works, this could offer a new treatment option to control low-grade serous ovarian cancer before and after surgery.
- What could go wrong
- This is a very small pilot study with only 18 participants, so results may not apply to all patients. The drugs are already approved for other cancers but are experimental for this type of ovarian cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Aug 2019
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with clinical or surgical stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who in the judgement of the treating physician are unlikely to achieve optimal surgical cytoreduction and have been recommended to receive neoadjuvant therapy. 2. Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center. 3. Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion. 4. Willingness to provide pre- and post-treatment tissue for translational studies. Pre-treatment fresh frozen tissue must be available for research purposes. This tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy. 5. Signed informed consent on protocol LAB02-188. 6. Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion. 7. Patients whose clinical biopsies are found to be insufficient for the planned translational studies must be willing to undergo a research biopsy. 8. Patients must have measurable disease by RECIST v1.1. a. Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be \>20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>10 mm when measured by spiral CT. 9. Women 18 years of age or older. 10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 11. Abnormal organ function is permitted. However, patients must have: a. absolute neutrophil count \>/= 1500/mL b. platelets \>/= 100,000/mL c. hemoglobin \>/= 9 g/dL d. estimated creatinine clearance \>/= 60 ml/min as calculated using the method standard for the institution e. total serum bilirubin \</= 1.5 X ULN f. aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) \</= 3 X ULN (\</= 5 X ULN in patients with bone or liver metastases) 12. Resolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE 4.03 Grade \</= 1 13. Women of child-bearing potential (intact uterus) MUST have a negative serum or urine human chorionic gonadotropin (HCG) test within 72 hours prior to receiving the first dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 14. Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 7.7). Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately 15. Pre/perimenopausal women must be amenable to be treated with goserelin. All patients will be rendered post-menopausal secondary to concomitant administration of goserelin. 16. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures. Exclusion Criteria: 1. Patients who are pregnant or breastfeeding. 2. The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 3. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Concomitant Medications section), and drugs that are known to prolong the QT interval (see Prohibited Concomitant Medications in section 7.6.2). 4. Diagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 5. Previous chemotherapy or hormonal therapy for treatment of ovarian cancer. 6. Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection. 7. Inability or unwillingness to swallow pills. 8. Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization. 9. Inability to comply with the study and follow-up procedures. 10. History of any of the following: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), sudden cardiac arrest. 11. Prior hematopoietic stem cell or bone marrow transplantation. 12. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable). 13. Known or possible hypersensitivity to fulvestrant, or abemaciclib or any of their excipients. 14. Pre/perimenopausal women with a known hypersensitivity to gnRH (gonadotropin-releasing hormone) agonists.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Low grade serous ovarian carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New hope for rare ovarian cancers: drug combo trial launches
- Can avastin stop ovarian cancer from coming back?
- Breathing in chemo: new hope for lung metastases?
- Bacteria bombs target stubborn tumors in new cancer combo trial
- Home workouts may help endometrial cancer survivors shed pounds
- New drug combo aims to control Hard-to-Treat cancers