Clinical trial NCT03527888: Study of Anlotinib in Patients With Primary Malignant Bone Tumors
Official title: A Single-Arm, Open-Label, Multicenter Clinical Trial With Anlotinib Hydrochloride Capsule for Primary Malignant Bone Tumors With Recurrence and Distant Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoplasm of Bone
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of patients with recurrent and metastatic bone tumors.


Eligibility criteria: Inclusion Criteria:

1. The patient volunteered to participate in this study and signed an informed consent;
2. Pathological diagnosis of osteosarcoma, chondrosarcoma, source of undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, derived bone giant cell tumor of bone or bone primary Ewing's sarcoma / primitive neuroectodermal tumor (PNET) tumor;
3. All patients were failed in chemotherapy (including anthracycline) or intolerance, recurrence or distant metastasis, and at least one measurable lesion (according to RECIST 1.1 criteria);
4. At the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2;
5. ECOG PS score: 0\~1 score (amputation patient's PS score is 0\~2), and the expected survival time is over March;
6. The main organs function within 7 days before the treatment, in accordance with the following criteria: the standard of blood routine examination (in 14 days without blood transfusion): The hemoglobin is greater than or equal to 90g/L (by multiple tumor metastasis induced anemia, hemoglobin = 85g/L); The neutrophil absolute value is more than 1.5 \* 109/L; Platelet over 80 \* 109/L. biochemical examination should comply with the following criteria: The total bilirubin is less than or equal to 1.5 Long ULN; The alanine aminotransferase and aspartate aminotransferase is less than or equal to 2.5ULN, such as liver metastasis, ALT and AST = 5ULN; The serum creatinine or creatinine clearance rate is greater than 1.5ULN 60ml/min; Doppler ultrasound assessment of the lower limit of normal value is more than the left ventricular ejection fraction (50%).
7. Women of childbearing age should use contraceptive measures must be agreed within 6 months in the study period and after the end of the study (such as IUD, pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test is negative, and must be for patients with non lactation; men should agree to use contraceptive measures must be 6 months in the research period and the end of the study period after the patients.

Exclusion Criteria:

- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C

Primary outcomes:
measure: Progress free survival (PFS)
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 10 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Shanghai
country: China
facility: Shanghai No.6 People's Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Yang Yao
role: PRINCIPAL_INVESTIGATOR
References: