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

NCT03026881 | Unknown Phase 1

• 1 other identifier: FZPL-I-103-GC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent and Metastatic Gastric Cancer

Keywords

PARP inhibitor; VEGFR inhibitor; Combination therapy; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  DLT and safety defined by CTC version 4.0

  through study completion, an average of 6 months

Secondary Outcomes (10)

• Best of ORR

  through study completion, an average of 6 months

• Overall Response Rate (ORR)

  through study completion, an average of 6 months

• Disease Control Rate (DOR)

  through study completion, an average of 6 months

• Time to Progression (TTP)

  From date of enrollment until the date of first objective progression, assessed up to 9 months

• Progression Free Survival (PFS)

  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

Study Arms (1)

Fluzoparib + Apatinib + Paclitaxel

EXPERIMENTAL

Drug: Fluzoparib; Drug: Apatinib; Drug: Paclitaxel

Interventions

Fluzoparib DRUG

Fluzoparib either at 20,30,40mg twice daily,capsule oral.

Also known as: SHR3162

Fluzoparib + Apatinib + Paclitaxel

Apatinib DRUG

Oral

Fluzoparib + Apatinib + Paclitaxel

Paclitaxel DRUG

Intravenous injection

Fluzoparib + Apatinib + Paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: collaborator

Study Sites (1)

The Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Stomach Neoplasms

Interventions

fluzoparib; apatinib; Paclitaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Jianming Xu, MD

CONTACT

jmxu2003@yahoo.com

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: December 21, 2016
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

CN (1)