A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

March 5, 2017 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer

Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Affiliated Hospital of Military Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
  • Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
  • Subjects who have overall good overall general condition.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who received any previous treatment with any PARP inhibitors.
  • Subjects who received any previous treatment with any taxanes.
  • More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
  • Less than 4 weeks from the last clinical trial.
  • Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  • Unstable hypertension.
  • Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
  • Subjects with brain metastases.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel 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.
  • Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluzoparib + Apatinib + Paclitaxel
Drug: Paclitaxel
Intravenous injection
Drug: Apatinib
Oral
Drug: Fluzoparib
Fluzoparib either at 20,30,40mg twice daily,capsule oral.
Other Names:
  • SHR3162

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
Time Frame: through study completion, an average of 6 months
DLT and safety defined by CTC version 4.0
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Best of ORR
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Overall Response Rate (ORR)
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Disease Control Rate (DOR)
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Time to Progression (TTP)
Time Frame: From date of enrollment until the date of first objective progression, assessed up to 9 months
From date of enrollment until the date of first objective progression, assessed up to 9 months
Progression Free Survival (PFS)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
Maximum plasma concentration (Cmax)
Time Frame: Up to 33 days
Up to 33 days
Terminal half life (t1/2)
Time Frame: Up to 33 days
Up to 33 days
Area under the plasma concentration-time curve (AUC）
Time Frame: Up to 33 days
Up to 33 days
Volume of distribution (V/F)
Time Frame: Up to 33 days
Up to 33 days
Plasma Clearance (CL/F)
Time Frame: Up to 33 days
Up to 33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZPL-I-103-GC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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