A Clinical Trial of Apatinib Plus Docetaxel in Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma

Sponsor
Sir Run Run Shaw Hospital
Study ID
NCT03071042
Phase
PHASE1
Status
Unknown

Conditions

  • Metastatic Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib Mesylate Tablets 425mg (500mg，675mg or 750mg) po. qd continuous;
  • Docetaxel — DRUG
    Docetaxel 60mg/m2 ivgtt day 1, q21d Combined use of Docetaxel and Apatinib

Study Details

This study evaluated the tolerance, safety and efficacy of Apatinib plus Docetaxel as the second-line treatment in locally advanced or metastatic gastric cancer (including Gastroesophageal junction (GEJ) Adenocarcinoma).

Key Dates

Start date
Oct 31, 2015
Status verified
Feb 2017
Primary completion
Dec 31, 2017
Completion
Jun 30, 2018

Study Design

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

Arms

  • Experimental: Apatinib plus Docetaxel
    Each subject will receive one dose of Apatinib in the whole cycle (21 days), during which single dose induced DLT and safety monitoring will be performed. If the initial dose is well tolerated, next cycle the subject will receive more Apatinib as respectively. This study will enroll in 4 cohorts of Apatinib; cohort 1 at the dose of 425mg Apatinib, which followed by cohort 2(500mg), cohort 3(675mg) and cohort 4(750mg).

Primary Outcome Measure

Tolerance profile of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: At least 4 weeks ]

Central Contacts

  • Hongming Pan, MD
    +86-13605716662

Related Studies