Clinical trial NCT02575651: A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Keywords: PARP
Advanced Solid Malignancies
Fluzoparib
Ovarian Cancer
BRCA
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: 307 Hospital of PLA
name: Peking University Cancer Hospital & Institute
First posted: 2015-10-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax
timeFrame: 4 weeks
measure: Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax
timeFrame: 4 weeks
measure: Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2
timeFrame: 4 weeks
measure: Evaluation of pharmacokinetic parameter of Fluzoparib: AUC
timeFrame: 4 weeks
measure: Preliminary antitumor activity for the regimen, objective response rate(ORR)
timeFrame: 8 weeks
measure: Number of participants with adverse events.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.307 Hospital, Academy of Military Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: