Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

NCT04376073 | Unknown Phase 2 DMC

• 1 other identifier: 2019-FXY-357
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

At present, the standard treatment for platinum-resistant ovarian cancer patients is platinum-free chemotherapy, with poor efficacy and tolerance. The combination of anti-angiogenic drugs and PARPi can play a synergistic anti-tumor role and achieve good efficacy in platinum-sensitive recurrent ovarian cancer. This study intends to explore the safety and effectiveness of anlotinib and niraparib dual therapy in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (ovarian cancer).

Conditions

Platinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The primary objective of this study is to determine the preliminary efficacy of administration of niraparib in combination with anlotinib in the treatment of platinum-resistant recurrent ovarian cancer, as measured by the objective response rate (ORR), which is a combination of CR (the target lesion completely disappeared over 4 weeks) and PR (Target lesions were reduced by more than 30% for more than 4 weeks).

  at 6 months

Secondary Outcomes (3)

• The frequency and severity of adverse events

  Baseline through 1 year

• Progression-free survival

  at 6 months

• Objective tumor response

  at 6 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh \<77 kg) po QD day1\~21, Anlotinib 12mg po QD day1\~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.

Drug: Niraparib; Drug: Anlotinib

Interventions

Niraparib DRUG

Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh \<77 kg) po QD day1\~21, Anlotinib 12mg po QD day1\~14

Treatment group

Anlotinib DRUG

Anlotinib 12mg po QD day1\~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol; 2. 18 \~ 70 years old (inclusive), female; 3. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer; 4. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; 5. Life expectancy \> 16 weeks; 6. Patient's ECOG physical status score is 0-1; 7. Subject agrees to take blood samples for gBRCA mutations; 8. Can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination repair-related genes detection (optional); 9. Good organ function, including:
• Neutrophil count \>= 1500 / μL;
• Platelets \>= 100,000 / μL;
• Hemoglobin \>= 9g / dL;
• Serum creatinine \<= 1.5 times the upper limit of normal value, or creatinine clearance \>= 60mL / min (calculated according to Cockcroft-Gault formula);
• Total bilirubin \<= 1.5 times the upper limit of normal value or direct bilirubin \<= 1.0 times the upper limit of normal value;
• AST and ALT \<= 2.5 times the upper limit of normal value. When liver metastases are present, it must be \<= 5 times the upper limit of normal value.
• \. The toxic side effects of any previous chemotherapy have recovered to \<= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms \<= CTCAE level 2.

You may not qualify if:

• People who are known to be allergic to Niraparib or Anlotinib (or active or inactive ingredients of drugs with similar chemical structure);
• Symptomatic, uncontrolled brain or pia mater metastases;
• Underwent major surgery within 3 weeks before the study began or has not recovered after surgery;
• Received palliative radiotherapy of \> 20% bone marrow 1 week before enrollment;
• Have invasive cancer other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 2 years before enrollment;
• Patients with central lung squamous cell carcinoma or at risk for large hemoptysis;
• Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, inability to swallow or gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections; mental illnesses that affect patients' signed informed consent History of bleeding tendency and thrombosis; history of severe cardiovascular disease;
• Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities;
• Receive platelet or red blood cell transfusions within 4 weeks;
• Patients who are pregnant or nursing, or who plan to become pregnant during study treatment;
• Have previously received any PARP inhibitor treatment.

Sponsors & Collaborators

• Jihong Liu: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

• Deng T, Yan L, Li J, Liu G, Yin A, Feng Y, Zheng M, Zhang C, Huang H, Huang Q, Lin A, Jiang J, Kong B, Liu J. Adverse Event Management in Patients with Platinum-Resistant Ovarian Cancer Treated with Niraparib and Anlotinib: Updates from the Phase II, Multi-Center ANNIE Study. Ther Clin Risk Manag. 2025 Jul 21;21:1135-1147. doi: 10.2147/TCRM.S526755. eCollection 2025.

  PMID: 40718116 DERIVED

• Liu G, Feng Y, Li J, Deng T, Yin A, Yan L, Zheng M, Xiong Y, Li J, Huang Y, Zhang C, Huang H, Wan T, Huang Q, Lin A, Jiang J, Kong B, Liu J. A novel combination of niraparib and anlotinib in platinum-resistant ovarian cancer: Efficacy and safety results from the phase II, multi-center ANNIE study. EClinicalMedicine. 2022 Nov 30;54:101767. doi: 10.1016/j.eclinm.2022.101767. eCollection 2022 Dec.

  PMID: 36583171 DERIVED

MeSH Terms

Interventions

niraparib; anlotinib

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: May 1, 2020
• First Posted: May 6, 2020
• Study Start: May 22, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within six months after the trial complete

Locations

CN (1)