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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