A Study of Anlotinib in Subjects With Advanced Malignancy

NCT04216082 | Completed Phase 2

• 1 other identifier: ALTN-00-II
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Anlotinib is a tyrosine kinase inhibitors (TKI) with high effective in inhibiting angiogenesis and tumor cell proliferation by targeting VEGFR, PDGFR, FGFR and c-Kit. Previous phase I trial has shown the potency of anlotinib in treating patients with various cancer types who failed in standard treatment or lack proper treatment regimen. Here, a single center, single-arm, phase II study was conducted to further validate the efficacy and safety of anlotinib in these patients.

Conditions

Advanced Malignancy

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Percentage of subjects achieving complete response (CR) and partial response (PR).

  up to 96 weeks

Secondary Outcomes (3)

• Progression-free survival (PFS)

  up to 96 weeks

• Disease control rate（DCR）

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

Study Arms (1)

Anlotinib

EXPERIMENTAL

Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib is a oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis as well as cell proliferation simultaneously and have been approved to treat advanced non-small cell lung cancer (NSCLC) in China. Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 18\~70 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
• \) Histopathologically confirmed advanced malignancy, including gynecological-related tumors, breast cancer, digestive tract tumors, melanoma, and gastrointestinal stromal tumors.
• \) Has no effective treatment choice, or failure/recurrence after conventional treatment.
• \) If has received chemotherapy, the treatment has been discontinued for at least 30 days.
• \) The main organs function are normally. 6) Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
• \) Understood and signed an informed consent form.

You may not qualify if:

• ）Has other malignant tumors. 2) Has participated in other anticancer drug clinical trials within 4 weeks. 3) Has multiple factors affecting oral medication. 4) Has brain metastasis, spinal cord compression, cancerous meningitis. 5) Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
• \) Has any serious and / or uncontrolled disease. 7) Long-term unhealed wounds or fractures. 8) Has artery/venous thrombosis prior to the first dose within 6 months. 9) Has bleeding tendency or treated with anticoagulants or vitamin K antagonists.
• \) Has drug abuse history that unable to abstain from or mental disorders. 11)Has history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
• \) According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

anlotinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: August 1, 2013
• Primary Completion: August 31, 2014
• Study Completion: August 1, 2015
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

CN (1)