A Study of Anlotinib in Subjects With Advanced Malignancy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Anlotinib 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
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).
|
Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) [up to 96 weeks]
Percentage of subjects achieving complete response (CR) and partial response (PR).
Secondary Outcome Measures
- Progression-free survival (PFS) [up to 96 weeks]
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Disease control rate(DCR) [up to 96 weeks]
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
- Duration of Response (DOR) [up to 96 weeks]
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- 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.
Exclusion Criteria:
- 1)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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing | China | 100021 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALTN-00-II