A Study to Explore Pamiparib Treatment in Epithelial Ovarian Cancer After Prior PARP Inhibitor Exposure

NCT05489926 | Unknown Phase 2 DMC

• 1 other identifier: PamiAP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The PamiAP will be a Phase II, single-arm, open label study to explore the efficacy and safety of Pamiparib treatment in patients with Epithelial Ovarian Cancer（EOC） who have had exposure to prior a PARP (poly(ADP-ribose)-polymerase) inhibitor

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• CBR at 4 months

  Clinical Benefit Rate (CBR) was defined as percentage of participants with confirmed best overall response of complete response (CR), partial response (PR), stable disease (SD) sustained for at least 4 months was assessed by investigators according to RECIST v1.1

  Up to approximately 18 months

Secondary Outcomes (4)

• PFS

  Up to approximately 18 months

• ORR

  Up to approximately 18 months

• DOR

  Up to approximately 18 months

• AE

  Up to approximately 21 months

Study Arms (1)

Pamiparib

EXPERIMENTAL

Drug: Pamiparib

Interventions

Pamiparib DRUG

Pamiparib, 60mg PO BID

Pamiparib

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 signature of informed consent;
• Age ≥18;
• Histologically diagnosed relapsed non-mucinous epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer), including platinum-sensitive and platinum-resistant patients, and the proportion of platinum-resistant patients was less than 40%
• ≥2 previous lines of treatment
• Patients must have received one prior PARP inhibitor therapy:
• Prior PARP inhibitor for maintenance treatment: the duration of prior PARP inhibitor exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second or subsequent line of chemotherapy
• Prior PARP inhibitor for treatment: the duration of prior PARP inhibitor exposure must have been ≥4 months
• Patients must have lesions that can be measured according to RECIST v1.1 criteria;
• Life expectancy ≥16 weeks;
• Eastern United States Cancer Collaboration Group (ECOG) score 0-1;
• Pregnant women must agree to effective contraception ≥120 days during the study period and after the last drug administration, and the results of serum pregnancy tests were negative 7 days ≤ before the first drug administration;
• Patients must have adequate organ function as indicated by the following laboratory values:
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelets ≥ 80 x 109/L

You may not qualify if:

• Prior treatment with Pamiparib;
• Patients who are candidates for surgery after disease progression;
• Patients who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anti-cancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy;
• Patients who have undergone major surgery/surgical therapy for any cause ≤ 4 weeks prior to starting study drug. Patients must have adequately recovered from the treatment and have a stable clinical condition before entering the study;
• Patients who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Patients must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study;
• Untreated and/or active brain metastases; i. A scan to confirm the absence of brain metastases is not required ii. Patients with treated brain metastases must be off corticosteroids for ≥ 14 days and have no signs or symptoms of progressive brain metastases
• Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation
• Patients with any of the following cardiovascular criteria:
• i. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days prior to Day 1 ii. Evidence of symptomatic pulmonary embolismwithin 4 weeks prior to Day 1 iii. Acute myocardial infarction ≤ 6 months prior to Day 1 iv. Heart failure of New York Heart Association Classification III or IV (see Appendix 12) ≤ 6 months prior to Day 1 v. ≥ Grade 2 ventricular arrhythmia ≤ 6 months prior to Day 1 vi. Cerebrovascular accident ≤ 6 months prior to Day 1
• Patients with other malignant cancer i. Except for surgically excised non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated low-stage bladder cancer, ductal carcinoma in situ treated surgically with curative intent, or a malignancy diagnosed ≥ 5 years ago with no current evidence of disease and no therapy ≥ 5 years prior to Day 1
• Diagnosis of myelodysplastic syndrome (MDS);
• Known human immunodeficiency virus (HIV) infection, active viral hepatitis, or active tuberculosis;
• Use ≤ 10 days (or ≤ 5 half-lives, whichever is shorter), prior to Day 1, or anticipated need for food or drugs known to be strong or moderate cytochrome P450 (CYP) 3A inhibitors or strong CYP3A inducers;
• Pregnancy or nursing:
• i. Females of childbearing potential require a negative serum pregnancy test ≤ 7 days before Day 1.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

pamiparib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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 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: August 4, 2022
• First Posted: August 5, 2022
• Study Start: August 16, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

CN (1)