Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT05494580|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2022
Last Update Posted : August 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Ovarian Carcinoma Platinum-resistant Ovarian Cancer Fallopian Tube Carcinosarcoma Primary Peritoneal Cancer||Drug: Pamiparib Drug: Surufatinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Drug: Pamiparib Drug: Surufatinib|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||August 10, 2022|
|Estimated Primary Completion Date :||August 10, 2024|
|Estimated Study Completion Date :||August 10, 2025|
Experimental: Pamiparib + Surufatinib (Phase Ib/II)
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.
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.
Other Name: Poly (ADP-ribose) polymerase (PARP) inhibitor
Other Name: Tyrosine Kinase Inhibitor
- Maximum tolerated dose (MTD) (Phase Ib) [ Time Frame: first 21 days of treatment ]MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a dose limiting toxicity (DLT) during the first cycles. DLT is defined as: grade 3 febrile neutropenia, grade 4 hematologic toxicities, and ≥ grade 3 non-hematologic toxicities that occurred within the first cycle of treatment with pamiparib and surufatinib.
- Recommended Phase 2 dose (RP2D) (Phase Ib) [ Time Frame: first 21 days of treatment ]Determine the RP2D of the pamiparib and surufatinib combination
- Response Rate (ORR) (Phase II) [ Time Frame: from the first drug administration up to two years ]ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Progression-free Survival (PFS) [ Time Frame: from the first drug administration up to two years ]Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.
- Disease Control Rate (DCR) [ Time Frame: from the first drug administration up to two years ]Proportion of patients whose best overall response is either CR, PR, or SD.
- Duration of response (DOR) [ Time Frame: from the first drug administration up to two years ]Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: from the first drug administration up to 2 years ]Time from the date of first study treatment administration to the date of death due to any cause.
- Safety and tolerability [ Time Frame: up to 90 days after last study treatment administration ]Incidence, nature, and severity of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Patient Reported Outcomes (PROs) [ Time Frame: from the first drug administration up to two years ]Determination of changes in PROs with Functional Assessment of Cancer Therapy for patients with ovarian cancer (FACT-O) questionnaire
- Biomarkers associated with the response to pamiparib combined with surufatinib [ Time Frame: from the first drug administration up to two years ]To identify the biomarkers, including but not limited to genomic, homologous recombination deficiency (HRD), that predict the efficacy of this study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494580
|Contact: Chunyan Lan, M.D.||email@example.com|