Study on the Efficacy and Toxicity of Pamiparib Combined With Tamoxifen in the Treatment of Epithelial Ovarian Cancer Patients With Biochemical Recurrence During First-line PARPi Maintenance Therapy

NCT05669768 | Unknown Phase 2

• 1 other identifier: PATAOC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase II single arm prospective clinical study is to evaluate the efficacy and toxicity of pamiparib + tamoxifen regimen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy. The main questions it aims to answer are:

• Effect of the regimen on the reduction of CA125
• The delayed effect of treatment regimens on the patient's radiographic progression

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate by CA-125

  Best overall response in patients without initial measurable disease and who are evaluable by CA 125 is according to the Gynecological Cancer Intergroup (GCIG)

  Up to approximately 24 months

Secondary Outcomes (4)

• PFS (progression-free survival)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• TFST (Time to first subsequent therapy)

  TFST was defined as the time from the onset of patient enrollment to the time of first subsequent treatment or death, whichever occurs first, up to 24 months.

• The percentage of subjects discontinued study treatment due to adverse events assessed according to NCI-CTCAE v5.0.

  Up to approximately 24 months

• EORTC-QLQ-C30（EORTC Core Quality of Life questionnaire）

  Up to approximately 24 months

Study Arms (1)

pamiparib+tamoxifen

EXPERIMENTAL

Drug: Pamiparib/Tamoxifen

Interventions

Pamiparib/Tamoxifen DRUG

Pamiparib 40mg PO BID, Tamoxifen 20mg PO BID

pamiparib+tamoxifen

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and signing of the consent form;
• Age ≥ 18 years;
• Histologically confirmed malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, including high-grade serous cancer, low-grade serous cancer, endometrioid cancer, and clear cell cancer;
• Patients with ovarian cancer reaching NED (no evidence of disease) or CR/PR in the last platinum containing chemotherapy after full staging or tumor cell reduction surgery (CA125 is required to be reduced to the normal range);
• Has received first-line maintenance treatment of PARP inhibitor in the past, and the time from first-line maintenance treatment of PARP inhibitor to biochemical recurrence is required to be ≥ 12 months;
• The type of PARP inhibitor used in the past is not limited, and it is allowed to change the type of PARP inhibitor due to non disease progression;
• CA-125 increased more than twice the upper limit of normal value again, but imaging examination showed no evidence of tumor recurrence;
• The expected life span is more than 3 months;
• The ECOG score of the Eastern Tumor Cooperation Group was 0-1;
• The main organs function well, which is defined as:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10L
• Platelet count (PLT) ≥ 75 × 10L
• Hemoglobin ≥ 9gdL
• Serum creatinine Cr\<1.5 × Upper limit of normal value (ULN)
• Total serum bilirubin ≤ 1.5 × Upper limit of normal range (ULN)

You may not qualify if:

• Patients with other malignant tumors (except for patients with carcinoma in situ who have been fully treated and have no disease evidence, except for patients with thyroid cancer who have completed radical treatment, and patients with other malignant tumors who have completed radical treatment and have been screened for more than 5 years from the last tumor related treatment);
• Imaging evaluation showed clear evidence of tumor recurrence or progression;
• Pregnancy and perinatal patients;
• Active pneumonia not cured;
• History of important organ transplantation;
• History of serious mental illness and brain dysfunction;
• Drug abuse or drug abuse history;
• Any active autoimmune disease or patient with a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hypophysitis, vasculitis, uveitis) or patients who need systemic hormone therapy and/or immunosuppression therapy (such as asthma requiring bronchodilators); Except for the following: vitiligo, alopecia, Graves syndrome, psoriasis or eczema that do not need systematic treatment in the past 2 years, stable immune thyroiditis that has been controlled after treatment, type I diabetes that only needs stable insulin, and childhood asthma has been completely alleviated;
• The immunosuppressant or systemic hormone therapy is being used to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other equivalent hormone preparations), and it is still used 2 weeks before enrollment. Local and systemic use of prednisone or other equivalent hormone preparations not exceeding 10mg/day is allowed;
• Patients with active bleeding (bleeding caused by tumor needs to be evaluated by the researcher), bleeding tendency or risk of massive bleeding (such as tumor involving large vessels, important bronchi, obvious bleeding beyond control after hemostasis treatment, and uncured bronchiectasis), or patients who need to be treated with coumarin anticoagulants at the same time;
• Thrombosis or embolism events occurred in the past 6 months, such as cerebrovascular accident (including transient ischemic attack);
• Serious cardiovascular disease or medical history includes but is not limited to the following:
• NYHA Grade 3 and 4 congestive heart failure within 6 months before enrollment
• Unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening
• Arrhythmias requiring treatment intervention (Patients with administration of β- receptor blockers or digoxin can be enrolled)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

pamiparib; Tamoxifen

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

jundong li

CONTACT

+86-20-87343104; lijd@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 3, 2023
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

CN (1)