Actively Recruiting
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
100
Participants Needed
12
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy and safety of abemaciclib and letrozole for treatment of estrogen receptor-positive rare ovarian cancer.
CONDITIONS
Official Title
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided voluntary written informed consent before any screening
- Using highly effective birth control methods during the study
- Histologically confirmed low-grade serous, low-grade endometrioid carcinoma of ovary, fallopian tube, peritoneum, or adult type granulosa-cell tumor with estrogen receptor positivity
- For Stage 1 and Stage 2 cohorts, patients must have platinum as a treatment option with no limit on prior chemotherapy and up to two prior endocrine therapies; patients without platinum option allowed in Stage 2 with similar limits; no chemotherapy for platinum resistant or refractory disease
- Age over 18 years at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Recurrent, measurable disease by RECIST v1.1 criteria
- Mandatory pre- and post-treatment tissue biopsy and ct-DNA blood samples
- Prior treatment with letrozole or aromatase inhibitor allowed but capped at 10 patients per cohort
- Completed and recovered from radiotherapy effects with at least 14 days washout
- No remaining ovarian function or confirmed menopause or placed on hormonal suppression after negative pregnancy test
- Adequate organ function according to specified blood count and liver/kidney test thresholds
You will not qualify if you...
- Platinum refractory patients and those without platinum option not allowed in Stage 1; platinum refractory not allowed in Stage 2; must have recovered from chemotherapy effects with at least 21 days washout
- Serious medical conditions like interstitial lung disease, severe breathing problems, severe kidney impairment, major gastrointestinal surgery, or chronic bowel disease causing baseline moderate or worse diarrhea
- Current use of strong CYP3A4 inhibitors or inducers
- Diagnosis of another cancer within 3 years except treated skin cancer or cervical carcinoma in situ
- Prior treatment with any cyclin dependent kinase inhibitor
- Known infection with Hepatitis B, Hepatitis C, or HIV
- Unable or unwilling to swallow pills
- Major surgery within 14 days before study drug or not recovered from major side effects
- Active infections requiring IV antibiotics or antifungals or uncontrolled recurrent illness needing hospitalization
- History of serious heart rhythm problems or sudden cardiac arrest
- Prior stem cell or bone marrow transplant
- Known active brain metastases; stable treated brain metastases allowed
- Blood clotting disorders or anticoagulant use preventing certain injections
- Known allergy to letrozole, abemaciclib, or their ingredients
- Hypersensitivity to gonadotropin-releasing hormone agonists in pre/perimenopausal women
- Pregnant or breastfeeding
- Participation in another investigational drug or incompatible medical research trial within 30 days or 5 half-lives prior to this study start, or currently enrolled in incompatible medical research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
CHU de Liège
Liège, Liège, Belgium, 4000
Actively Recruiting
2
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
3
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
4
Institut De Cancerologie Strasbourg Europe
Strasbourg, Bas-Rhin, France, 67200
Actively Recruiting
5
Institut Bergonie
Bordeaux, Gironde, France, 33000
Actively Recruiting
6
Institut Universitaire Du Cancer Toulouse-Oncopole
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
7
Institut De Cancerologie De L'Ouest
Saint-Herblain, Loire-Atlantique, France, 44800
Actively Recruiting
8
Centre Leon Berard
Lyon, Métropole de Lyon, France, 69008
Actively Recruiting
9
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, France, 75020
Actively Recruiting
10
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
11
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
12
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
Research Team
E
Els Van Nieuwenhuysen, MD PhD
CONTACT
T
Tine Ottenbourgs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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