A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

Ovarian Cancer Clinical Trial

Official title:

An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075462
• Other study ID #: FZPL-I-104-OC/BC
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2017
• Est. completion date: December 13, 2021

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 13, 2021
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Life expectancy of more than 12 weeks.

• Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer,primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC), that is locally advanced or metastatic, are also eligible.

• Prior therapy:subjects with ovarian cancer,primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.

• At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline

• Subjects who have overall good overall general condition.

• Signed informed consent.

Exclusion Criteria:

• Subjects who received any previous treatment with any PARP inhibitors.

• Subjects who received any previous treatment with any VEGFR inhibitors.

• Less than 4 weeks from the last clinical trial.

• Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.

• Unstable or uncontrolled hypertension.

• Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.

• Subjects with brain metastases.

• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.

• Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.

• Ongoing infection (determined by investigator).

• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.

• Pregnant or breast-feeding women.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Fluzoparib
Fluzoparib either at 40,60,80mg twice daily,capsule oral.
• Apatinib
Apatinib at 250mg once daily, tablet oral

Locations

Country	Name	City	State
China	Beijing Cancer Hosptial	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The type and incidence of adverse events [safety and tolerability]	Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03	From screening up to 28 days after end of treatment
Secondary	Objective Response Rate (ORR)	[Complete response + Partial response (CR+PR)] based on RECIST 1.1	24 months (approx) from the start of treatment
Secondary	Disease Control Rate (DOR)	[Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1	24 months (approx) from the start of treatment
Secondary	Time to Progression (TTP)	The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients	From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months
Secondary	Overall Survival (OS)	Time from start of fluzoparib treatment until death due to any cause	From Cycle 1, Day 1 until death or up to 48 months (approx)
Secondary	Cmax	Maximum Plasma Concentration	From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Secondary	T1/2 (Half-life)	The time required for the plasma concentration of a drug to be reduced by 50%	From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Secondary	Area under curve (AUC)	Area under the plasma concentration-time curve	Within the first 5 weeks from start of fluzoparib treatment
Secondary	V/F	Volume of distribution	From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Secondary	CL/F	Plasma Clearance	From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment