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Trial Title: Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer

NCT ID: NCT05494580

Condition: Ovarian Cancer
Ovarian Carcinoma
Platinum-resistant Ovarian Cancer
Fallopian Tube Carcinosarcoma
Primary Peritoneal Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinosarcoma
Mixed Tumor, Mullerian
Pamiparib
Poly(ADP-ribose) Polymerase Inhibitors
Tyrosine Kinase Inhibitors

Conditions: Keywords:
Ovarian cancer
PARP inhibitor
Antiangiogenic agents
Platinum-resistant

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Drug: Pamiparib Drug: Surufatinib

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Pamiparib
Description: Oral
Arm group label: Pamiparib + Surufatinib (Phase Ib/II)

Other name: Poly (ADP-ribose) polymerase (PARP) inhibitor

Intervention type: Drug
Intervention name: Surufatinib
Description: Oral
Arm group label: Pamiparib + Surufatinib (Phase Ib/II)

Other name: Tyrosine Kinase Inhibitor

Summary: A number of studies suggest that the combination of PARP inhibitors and antiangiogenic agents produce synergistic activities. Pamiparib is a small molecule inhibitor selectivity for both PARP1 and PARP2. Surufatinib is a novel small-molecule inhibitor that simultaneously targets tumor angiogenesis (via Vascular Endothelial Growth Factor Receptor [VEGFR]1, VEGFR 2, VEGFR3 and Fibroblast Growth Factor Receptor 1 [FGFR1]) and immune evasion (via Colony Stimulating Factor 1 Receptor [CSF1R]). In this trial, we aimed to evaluate the efficacy, safety and tolerability of pamiparib in combination with surufatinib in patients with platinum-resistant ovarian cancer who received prior PARP inhibitors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Signed Informed Consent Form; 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3. Platinum-resistant disease, defined as progression within 6 months from completion of most recent platinum-containing therapy. Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance; 4. Patients must have received one prior PARP inhibitor therapy, and there must be a ≥ 6 month interval since treatment; 5. Female participants age 18-75 years; 6. Has measurable lesion per RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Life expectancy ≥ 3 months; 9. Patients must have normal organ and bone marrow function; 10. Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 6 months after the last dose of study drug(s). Exclusion Criteria: 1. Histological diagnosis of mucinous adenocarcinoma; 2. Has received prior therapy with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs); 3. Known or suspected allergy to any of study drugs; 4. Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York heart association [NYHA] class > 2, unstable angina, myocardial infarction, cardiac arrhythmia associated with hemodynamic instability (including corrected QT (QTc) interval ≥ 450 ms in men, ≥ 470 ms in female); 5. Has active ulcers, gastrointestinal perforation or obstruction; 6. Active bleeding or pathologic condition that carries a high risk of bleeding; 7. Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg) with or without treatment; 8. Major surgery within 28 days of starting study treatment; 9. Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g; 10. Uncontrolled pericardial or pleural or peritoneal effusions; 11. Has a diagnosed and/or treated additional malignancy within the last 5 years. Exceptions include in situ cervical cancer, non-melanoma skin cancer, or superficial bladder tumors that has undergone potentially curative therapy; 12. Known Human Immunodeficiency Virus (HIV) infection; 13. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 14. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University Cancer Cetntre

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Chunyan Lan

Phone: +862087343104
Email: lanchy@sysucc.org.cn

Investigator:
Last name: Chunyan Lan
Email: Principal Investigator

Start date: September 22, 2022

Completion date: August 10, 2025

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: Hutchmed
Agency class: Industry

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05494580

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