A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

An Open-label, Phase II Clinical Trial of of a Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Adverse Reactions Nausea of Niraparib in in the First-line Maintenance Treatment in Advanced Epithelial Ovarian Cancer (EOC) Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641506
• Other study ID #: YONNY-2002-080
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2022
• Est. completion date: May 2025

Study information

• Verified date: November 2022
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Guonan Zhang
• Phone: 86-13881866599
• Email: zhanggn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Description:

This study will investigate a Chinese Patent Medicine Yangzheng Xiaoji Capsule improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced EOC, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy. Approximately 50 eligible subjects are planned to be enrolled, given Yangzheng Xiaoji Capsule and niraparib maintenance treatment. The dosing regimen is:Niraparib 200mg QD combined with Yangzheng Xiaoji Capsule 0.36g*4 tid，28 days/cycle. Subjects will receive Niraparib plus Yangzheng Xiaoji Capsule up to 3 cycles.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign a written informed consent form before conducting any research-related procedures;

2. Women aged 18 or above;

3. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;

4. Life expectancy > 3 months;

5. Patients' ECOG physical condition score is 0-1, KPS score is =70;

6. Patients received = 3 cycles bevacizumab in combination within platinum-based chemotherapy

7. Good organ function, including:

• Neutrophil count = 1500/L
• Platelet = 100,000/L
• Hemoglobin =10g/dL
• Serum creatinine =1.5 times the upper limit of normal value, or creatinine clearance =60mL/min (according to Cockcroft-Gault Formula calculation)
• 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, and liver metastasis must be =5 times the upper limit of normal value.

7. No serious abnormalities of heart, brain, lung, liver and kidney function; 8. No serious mental illness; 9. Ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to =CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms =CTCAE 2 grade.

Exclusion Criteria:

1. People who are allergic to the ingredients in Yangzhengxiaoji Capsule

2. Have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy.

3. patients who are combined with other cancers;

4. Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Nausea
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Yangzheng Xiaoji
Chinese patent medicine Yangzheng Xiaoji capsule, 0.36g*4 tid,28 days as one cycle,up to 3 cycles.
• Niraparib
Niraparib 200 or 300mg* QD PO continually; *The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight <77 kg or platelets count <150,000/µL;300 mg QD for Patients with baseline body weight =77 kg and platelets count =150,000/µL.

Locations

Country	Name	City	State
China	Sicchuan cancer hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

References & Publications (11)

??,?.?????????????????????????Meta??[J].??????.2013,40(21):1318-1323.

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???.??????????????GP??????????????[J].??????.2019.12(5):62-64.

Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181. Erratum In: Ann Oncol. 2019 May 1;30(5):859. — View Citation

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Lord CJ, Ashworth A. PARP inhibitors: Synthetic lethality in the clinic. Science. 2017 Mar 17;355(6330):1152-1158. doi: 10.1126/science.aam7344. Epub 2017 Mar 16. — View Citation

Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7. — View Citation

Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510. — View Citation

Ramos-Esquivel A, Viquez-Jaikel A, Fernandez C. Potential Drug-Drug and Herb-Drug Interactions in Patients With Cancer: A Prospective Study of Medication Surveillance. J Oncol Pract. 2017 Jul;13(7):e613-e622. doi: 10.1200/JOP.2017.020859. Epub 2017 Jun 19. — View Citation

Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29. — View Citation

Ye L, Jia Y, Ji KE, Sanders AJ, Xue K, Ji J, Mason MD, Jiang WG. Traditional Chinese medicine in the prevention and treatment of cancer and cancer metastasis. Oncol Lett. 2015 Sep;10(3):1240-1250. doi: 10.3892/ol.2015.3459. Epub 2015 Jul 6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of anemia, thrombocytopenia, and neutropenia	Incidence of All Grade Anemia, Thrombocytopenia, Neutropenia within 3 Cycles (CTCAE V5.0)	3 cycles (each cycle is 28 days)
Other	Incidence of fatigue	Incidence of All Grade Fatigue Over 3 Cycles (CTCAE V5.0)	3 cycles (each cycle is 28 days)
Primary	Incidence of nausea	all grade of nausea base on CTCAE V5.0	3 cycles (each cycle is 28 days)
Secondary	Quality of life changes	base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score	3 cycles (each cycle is 28 days)
Secondary	PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months	PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months in patients with advanced ovarian cancer maintained on chemotherapy combined with bevacizumab switched nilaparib	up to 24 months