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

CTTQ

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Anlotinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332499

ALTN-07-IIB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 419 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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419 participants in 2 patient groups, including a placebo group

Anlotinib

Active Comparator group

Description:

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

Treatment:

Drug: Anlotinib

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo