A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.38 sites in 1 country378 target enrollmentJune 2015

ConditionsGastric Cancer

InterventionsAnlotinib Placebo

DrugsAnlotinib Placebo

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Gastric Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 378
Locations: 38
Primary Endpoint: Overall Survival (OS)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent;
•Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
•Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
•\>=18 years old；ECOG PS：0\~1；Estimated life expectancy \>3 months
•Main organs function is normal;

Exclusion Criteria

•Patients who have been treated with anlotinib previously;
•Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
•Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
•Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
•CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
•Patients with a clear tendency of gastrointestinal bleeding;
•Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
•Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
•Patients with any severe and/or unable to control diseases;
•Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;

Arms & Interventions

Anlotinib

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Intervention: Anlotinib

Placebo

Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Intervention: Placebo

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: From randomization until death (up to 24 months)

Secondary Outcomes

Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
Progress free survival (PFS)(each 42 days up to PD or death(up to 24 months))