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

NCT02575651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2019-06-17

No results posted yet for this study

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

Interventions

DRUG

Fluzoparib

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

Sponsors & Collaborators

  • 307 Hospital of PLA

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575651 on ClinicalTrials.gov