Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

NCT05311579 | Unknown Phase 2

• 1 other identifier: NIRAN1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased \> 35U/ml, and with no evidence of imaging recurrence, niraparib and anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer after achieving complete or partial remission to platinum-containing chemotherapy. The primary objective of this study is to explore the efficacy of niraparib combined with anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging recurrence. A total o f36 patients will be enrolled in this study.

Conditions

Ovarian Carcinoma; Survival Outcomes; Adverse Events; Niraparib; Anlotinib; CA125; Chemotherapy; Targeted Therapy; Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival (PFS) by RECIST v 1.1

  24 months

Secondary Outcomes (3)

• Time to first subsequent therapy (TFST)

  24 months

• Overall survival (OS)

  48 months

• Adverse events

  24 months

Study Arms (1)

Ovarian cancer patients with increased CA125

EXPERIMENTAL

Patients with CA125 \>35 U/ml or increased to 2 x nadir, and with no evidence of imaging recurrence after completion of 1st-line platinum-based chemotherapy

Combination Product: Niraparib plus anlotinib

Interventions

Niraparib plus anlotinib COMBINATION_PRODUCT

Niraparib QD D1-21 plus Anlotinib 10mg QD D1-14 until disease progression or intolerable toxicity 21days/cycle

Ovarian cancer patients with increased CA125

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent
• Patients must be female ≥18 years of age
• Patients must have histologically diagnosed non-mucinous ovarian cancer that is Stage III or IV according to FIGO criteria, and niraparib is used as 1st maintenance therapy after achieving CR/PR to front-line platinum-containing chemotherapy
• After completion of front-line platinum-based chemotherapy with a normal CA-125 concentration: CA-125 increased \> 35U/ml on 2 occasions (Repeat CA 125 any time but normally not less than 1 week after the first elevated CA 125 level), and with no evidence of imaging recurrence
• After completion of front-line platinum-based chemotherapy, CA125 decreased by 90% and was not in the normal range: the level of CA125 at the end of chemotherapy as the nadir, CA-125 increased to 2 x nadir on 2 occasions (Repeat CA 125 any time but normally not less than 1 week after the first elevated CA 125 level), and with no evidence of imaging recurrence
• Allow to combinate bevacizumab during front-line chemotherapy
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients must have adequate organ function, defined as follows:
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Hemoglobin ≥ 10 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation
• Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• Pregnancy test results were negative and patients willing to use appropriate contraceptive methods while in the trial and within 3 months after the last dose of this study treatment; or keep abstinence during the trial; or women with no potential fertility.

You may not qualify if:

• Allergy to active or inactive ingredients of niraparib or drugs with similar chemical structures.
• Allergy to active or inactive ingredients of anlotinib or drugs with similar chemical structures.
• 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 stable dose of hormone or do not need to take hormone).
• Major surgery performed within 3 weeks before enrollment, or any surgical effects that have not recovered from the surgery, or chemotherapy.
• Palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of the first dose of study treatment
• 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).
• Current or previous myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
• Other severe or uncontrolled diseases, including but not limited to:
• Uncontrollable nausea and vomiting, inability to swallow study drug, and any gastrointestinal disease that may interfere with the absorption and metabolism of the drug
• Active viral infections, such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus and so on
• Uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome or other psychiatric disorders that may affect patients' informed consent
• Immunodeficiency (except for splenectomy), or other diseases that investigators believe may expose patients to high-risk toxicity.
• Have the risk or tendency of bleeding and history of thrombosis
• CTCAE grade 2 bleeding event occurred within 3 months prior to screening or CTCAE ≥ grade 3 bleeding event occurred within 3 months prior to screening
• Have history of gastrointestinal bleeding or confirmed bleeding tendency within 6 months prior to screening. e.g. esophageal varices with bleeding risk, local active ulcer focus or fecal occult blood above ++

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib; anlotinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 5, 2022
• Study Start: March 27, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2024
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

CN (1)