NCT02575651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

3.2 years

First QC Date

October 8, 2015

Last Update Submit

June 13, 2019

Conditions

Advanced Solid Malignancies

Keywords

PARPAdvanced Solid MalignanciesFluzoparibOvarian CancerBRCA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax

    4 weeks

  • Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax

    4 weeks

  • Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2

    4 weeks

  • Evaluation of pharmacokinetic parameter of Fluzoparib: AUC

    4 weeks

  • Preliminary antitumor activity for the regimen, objective response rate(ORR)

    8 weeks

  • +1 more secondary outcomes

Study Arms (1)

Fluzoparib

EXPERIMENTAL

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.

Drug: Fluzoparib

Interventions

FluzoparibDRUG

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

Fluzoparib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

No.307 Hospital, Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100039, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 15, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

CN(2)