Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer (ANNIE)
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|ClinicalTrials.gov Identifier: NCT04376073|
Recruitment Status : Unknown
Verified November 2020 by Jihong Liu, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : May 6, 2020
Last Update Posted : November 25, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Platinum-resistant Ovarian Cancer||Drug: Niraparib Drug: Anlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (Ovarian Cancer)|
|Actual Study Start Date :||May 22, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Treatment group
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.
Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh <77 kg) po QD day1~21, Anlotinib 12mg po QD day1~14
Anlotinib 12mg po QD day1~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.
- Objective Response Rate [ Time Frame: at 6 months ]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).
- The frequency and severity of adverse events [ Time Frame: Baseline through 1 year ]The frequency and severity of adverse events and toxicity based upon NCI CTCAE version 5.0 during subjects receiving the study treatment.
- Progression-free survival [ Time Frame: at 6 months ]Progression-free survival is defined as the time from enrollment to first documentation of tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.
- Objective tumor response [ Time Frame: at 6 months ]The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 1. 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.
10. 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376073
|Sun Yat-Sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: guochen liu, Dr +86 13570314425 firstname.lastname@example.org|
|Sub-Investigator: guochen liu, Dr|
|Principal Investigator: Jihong Liu, Pro|
|Responsible Party:||Jihong Liu, professor, Sun Yat-sen University|
|Other Study ID Numbers:||
|First Posted:||May 6, 2020 Key Record Dates|
|Last Update Posted:||November 25, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||Within six months after the trial complete|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Molecular Mechanisms of Pharmacological Action