Ovarian CancerPhase 1/2NCT05494580
Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer
A Phase 1/2 study testing Pamiparib and Surufatinib in people with Ovarian Cancer and Ovarian Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Carcinoma, Platinum-resistant Ovarian Cancer
- What is being tested?
- Pamiparib and Surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2022to 31 Jan 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form;
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- 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;
- Patients must have received one prior PARP inhibitor therapy, and there must be a ≥ 6 month interval since treatment;
- Female participants age 18-75 years;
- Has measurable lesion per RECIST v1.1;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥ 3 months;
- Patients must have normal organ and bone marrow function;
- 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).
Who cannot join
- Histological diagnosis of mucinous adenocarcinoma;
- Has received prior therapy with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs);
- Known or suspected allergy to any of study drugs;
- 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);
- Has active ulcers, gastrointestinal perforation or obstruction;
- Active bleeding or pathologic condition that carries a high risk of bleeding;
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- Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg) with or without treatment;
- Major surgery within 28 days of starting study treatment;
- Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g;
- Uncontrolled pericardial or pleural or peritoneal effusions;
- 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;
- Known Human Immunodeficiency Virus (HIV) infection;
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pamiparib in Combination With Surufatinib in Patients With Platinum-resistant Ovarian Cancer Who Received Prior Poly (ADP-ribose) Polymerase (PARP) Inhibitors: a Multicenter, Single-arm, Phase Ib/II Trial
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.
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Fallopian Tube Carcinosarcoma, Primary Peritoneal Cancer
- Being tested
- Pamiparib, Surufatinib
- Keywords
- Ovarian cancer, PARP inhibitor, Antiangiogenic agents, Platinum-resistant
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamiparibDrug
Also called Poly (ADP-ribose) polymerase (PARP) inhibitor
Oral
SurufatinibDrug
Also called Tyrosine Kinase Inhibitor
Oral
| Study group | Role | What they receive |
|---|---|---|
| Pamiparib + Surufatinib (Phase Ib/II) | Experimental | Phase Ib:
A dose de-escalation schedule is used in the phase Ib dose finding part. Dose Level 1 (starting dose): pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 250 mg administered orally once daily on a 21-day treatment cycle. If ≥2/6 patients experience a dose limiting toxicity (DLT), we will de-escalate to Dose Level 2: pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 200 mg administered orally once daily on a 21-day treatment cycle. Approximately 3-12 patients will be enrolled in phase Ib study.
Phase II:
The phase II part will begin once the recommended phase 2 dose (RP2D) of surufatinib have been determined in the Phase Ib in order to assess antitumor activity of pamiparib and surufatinib combination. In phase II study, pamiparib 40 mg orally twice daily and surufatinib PR2D will be administered. Receives: Drug: Pamiparib; Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 dose (RP2D) (Phase Ib)
Determine the RP2D of the pamiparib and surufatinib combination
Measured: first 21 days of treatment
The 6-month progression-free survival (PFS) rate (Phase II)
The percentage of patients alive without documented progression 6 months after treatment initiation.
Measured: from the first drug administration up to two years
Secondary outcomes (6)
Objective response rate (ORR)
The proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: from the first drug administration up to two years
Disease Control Rate (DCR)
Proportion of patients whose best overall response is either CR, PR, or SD.
Measured: from the first drug administration up to two years
Duration of response (DOR)
Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first.
Measured: from the first drug administration up to two years
Overall survival (OS)
Time from the date of first study treatment administration to the date of death due to any cause.
Measured: from the first drug administration up to 2 years
Safety and tolerability
Incidence, nature, and severity of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: up to 90 days after last study treatment administration
Patient Reported Outcomes (PROs)
Determination of changes in PROs with Functional Assessment of Cancer Therapy for patients with ovarian cancer (FACT-O) questionnaire
Measured: from the first drug administration up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start22 Sep 2022
- Primary completion20 Jun 2024
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug: Pamiparib Drug: Surufatinib
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Hutchmed
- Responsible party
- Principal investigator, Xin Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494580
- Sponsor's protocol ID
- B2022-348-01
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided