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Safety, Tolerability and Pharmacokinetics of Simmiparib in Patients With Malignant Advanced Solid Tumor

NCT02993913 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-01-05

No results posted yet for this study

Summary

Phase I dose escalating trial. Primary objectives of this study are to assess the safety and tolerability of Simmiparib following single and multiple oral doses in patients with advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity (DLT), and pharmacokinetic profile.

The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.

Conditions

  • Malignant Advanced Solid Tumor

Interventions

DRUG

Simmiparib

Simmiparib Tablets, oral administration

Sponsors & Collaborators

  • Shanghai Acebright Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xichun Hu · Fudan University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-12-31

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 NCT02993913 on ClinicalTrials.gov