NCT04216082CompletedPhase 2
A Single Center, Single-arm, Phase II Study of Anlotinib in Subjects With Advanced Malignancy
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country93 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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).
Intervention: Anlotinib (Drug)
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: up to 96 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
Secondary Outcomes
- Progression-free survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Anlotinib Maintenance Treatment for Advanced Soft Tissue SarcomaSoft Tissue SarcomaNCT03890068Sun Yat-sen University49
Unknown
Phase 3
Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung CancerSmall Cell Lung CancerNCT04073550Chia Tai Tianqing Pharmaceutical Group Co., Ltd.184
Unknown
Phase 3
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung CancerSquamous Non-small Cell Lung CancerNCT04073537Chia Tai Tianqing Pharmaceutical Group Co., Ltd.386
Unknown
Phase 2
Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial CarcinomaUrothelial CarcinomaAnlotinibUrogenital NeoplasmsCisplatinCarboplatinGemcitabineAntineoplastic AgentsNCT05030077Tianjin Medical University Second Hospital53
Recruiting
Not Applicable
Prediction and Evaluation of Anlotinib Treatment Response Using Contrast Enhanced Ultrasound PPGL PatientsPheochromocytoma, MetastaticUltrasonographyParaganglioma, MalignantPheochromocytoma MalignantNCT06015061Peking Union Medical College Hospital20