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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03026881
Phase
PHASE1
Status
Unknown

Conditions

  • Recurrent and Metastatic Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    Fluzoparib either at 20,30,40mg twice daily,capsule oral.
  • Apatinib — DRUG
    Oral
  • Paclitaxel — DRUG
    Intravenous injection

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Mar 2017
Primary completion
Apr 30, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib + Apatinib + Paclitaxel

Primary Outcome Measure

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 ]

Central Contacts