Skip to main content
OpenTrials
Completed

NCT Number: NCT02332499

Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The 1st Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Loading trial locations.

About this study

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated informed consent；
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum；
  • Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
  • Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
  • ECOG PS:0-1,Life expectancy of more than 3 months；
  • main organs function is normal；
  • main organs function is normal；

Exclusion criteria

  • Prior treatment with Anlotinib；
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
  • Known brain metastases；
  • patients with severe and failed to controlled diseases；
  • patients occurred venous thromboembolic events within 6 months；

Treatment and study plan

Anlotinib

Drug

Anlotinib p.o. qd

Other names: AL3818

Placebo

Drug

Placebo p.o. qd

Primary outcomes

  1. Overall Survival (OS)

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

Secondary outcomes

  1. Progress free survival (PFS)

    Time frame: each 42 days up to PD or death(up to 24 months)

  2. Objective Response Rate (ORR)

    Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. Disease Control Rate (DCR)

    Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Until 30 day safety follow-up visit

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)

Acronym: ALTER0703

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jan 6, 2015
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.