Loading clinical trials...

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

An Open-Label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-Resistant Recurrent or Platinum-Refractory Clear Cell Ovarian Cancer.

NCT05130515•Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the ANNIE combo (anlotinib+niraparib). There is limited progress in targeted therapy for those less common ovarian cancers. In this study (CC-ANNIE), we aim to evaluate the antitumor activity and safety of niraparib combined with anlotinib in patients with platinum-resistant or platinum-refractory OCCC.

Detailed Description

The CC-ANNIE trial is a single-arm, single-center, exploratory phase II trial. Eligible patients (≥18 \& ≤70 years) are histologically confirmed platinum-resistant recurrent OCCC and 20 subjects are planned to be enrolled. All subjects must have measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and are going to be treated with niraparib 200mg once daily, anlotinib 10mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary endpoint is the objective response rate.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. The patients understood the test process, signed the informed consent form and agreed to participate in the study.
•2. 18 \~70 years old, female.
•3. Histologically confirmed ovarian clear cell carcinoma.
•4. The patients received platinum-based chemotherapy after primary debulking surgery, and experienced a recurrence or progression during the therapy; or experienced a recurrence or progression within 6 months after at least 4 cycles platinum-based therapy; or experienced a recurrence within 6 months after the end of the last platinum-based chemotherapy.
•Definition of recurrence or progression: clearly documented radiographic progression or carbohydrate antigen (CA125) increased continuously (confirmed after 1 week) and accompanied by clinical symptoms or physical examination, indicating disease progression.
•It is allowed to receive no more than 1 non-platinum regimen between 2 platinum-based regimens; Patients with disease recurrence or progression during platinum-based therapy or patients whose time from platinum-based treatment (at least 4 cycles) to disease recurrence and progression is less than 6 months are allowed to receive no more than 1 systematic treatment regimen.
•5. Expected survival more than 16 weeks.
•6. ECOG (Eastern Cooperative Oncology Group) physical status score 0-1.
•7. Good organ function.
•* Neutrophil counts ≥1500/µL
+10 more criteria

Exclusion Criteria

•1. Any poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors treatment history.
•2. Allergy to active or inactive ingredients of niraparib or drugs with similar chemical structures.
•3. Allergy to active or inactive ingredients of anlotinib or drugs with similar chemical structures.
•4. Active and uncontrollable brain metastasis or leptomeningeal metastasis. Patients with spinal cord compression can still be considered if they have received targeted treatment and have evidence of clinical stability of the disease for at least \> 28 days (controlled brain metastasis must have received radiotherapy or chemotherapy at least 1 month prior to study entry; patients may not have new symptoms related to brain lesions or symptoms indicating disease progression and either take a stable dose of hormone or do not need to take hormone).
•5. Major surgery performed within 3 weeks before enrollment, or any surgical effects that have not been recovered from the surgery, or chemotherapy.
•6. \>20% bone marrow palliative radiotherapy performed within 1 week before enrollment.
•7. Any other malignant tumor exclude ovarian cancer has been diagnosed within 2 years before enrollment (except for completely treated basal or squamous cell skin cancer).
•8. Combined with central squamous cell carcinoma of lungs or at risk of massive hemoptysis (such as bronchiectasis and uncured tuberculosis).
•9. Myelodysplastic syndromes (MDS) or acute myelocytic leukemia (AML).
•10. Serious or uncontrollable diseases, including but not limited to:
+23 more criteria

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

December 15, 2021

Primary Completion Date

January 1, 2023

Completion Date

January 1, 2023

Last Updated

January 31, 2023

Enrollment

ACTUAL participants

Conditions

Platinum-resistant Recurrent Clear Cell Ovarian Cancer

Interventions

Niraparib

DRUG

Anlotinib

DRUG