A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies

NCT ID: NCT02575651

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-06-30

Brief Summary

Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.

Conditions

Advanced Solid Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluzoparib

Each subject will receive a single dose of fluzoparib on day 1, and then subject will receive fluzoparib twice daily for 28 days during cycle 1.

Group Type: EXPERIMENTAL

Fluzoparib

Intervention Type: DRUG

Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.

Interventions

Fluzoparib

Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• At least one measurable lesion exists.(RECIST 1.1).
• Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
• Subjects who have overall good overall general condition.
• Signed informed consent.

Exclusion Criteria

• Subjects who received any previous treatment with a PARP inhibitor.
• Less than 4 weeks from the last clinical trial.
• Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy.
• Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
• Subjects with symptomatic uncontrolled brain metastases.
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects with a known hypersensitivity to Fluzoparib or any of the excipients of the product.
• Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

307 Hospital of PLA

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

No.307 Hospital, Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HR-FZPL-I-AST-TOL/PK

Identifier Type: -

Identifier Source: org_study_id