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

Advanced Solid Malignancies Clinical Trial

Official title:

A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of Fluzoparib Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575651
• Other study ID #: HR-FZPL-I-AST-TOL/PK
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2019
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	No.307 Hospital, Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	307 Hospital of PLA, Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.		4 weeks
Secondary	Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax		4 weeks
Secondary	Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax		4 weeks
Secondary	Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2		4 weeks
Secondary	Evaluation of pharmacokinetic parameter of Fluzoparib: AUC		4 weeks
Secondary	Preliminary antitumor activity for the regimen, objective response rate(ORR)	To evaluate ORR 8 weeks after the initiation of Fluzoparib	8 weeks
Secondary	Number of participants with adverse events.	Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0	8 weeks