Study of Anlotinib in Patients With Primary Malignant Bone Tumors

NCT ID: NCT03527888

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2019-12-31

Brief Summary

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

Conditions

Neoplasm of Bone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib

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

Group Type: OTHER

Anlotinib

Intervention Type: DRUG

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

Interventions

Anlotinib

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Yao

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Shanghai No.6 People's Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of the Air Force Medical University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ALTN-15-II

Identifier Type: -

Identifier Source: org_study_id