Study of Anlotinib in Patients With Primary Malignant Bone Tumors

NCT03527888 | Unknown Phase 2

• 1 other identifier: ALTN-15-II
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Neoplasm of Bone

Outcome Measures

Primary Outcomes (1)

• Progress free survival (PFS)

  From random grouping to the objective progression or death of a tumor

  through study completion, an average of 6 month

Secondary Outcomes (1)

• Overall Survival (OS)

  through study completion, an average of 10 month

Study Arms (1)

Anlotinib

OTHER

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

Drug: Anlotinib

Interventions

Anlotinib DRUG

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

Anlotinib

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteered to participate in this study and signed an informed consent;
• 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;
• 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);
• At the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2;
• ECOG PS score: 0\~1 score (amputation patient's PS score is 0\~2), and the expected survival time is over March;
• 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%).
• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

Study Sites (6)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Shanghai No.6 People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

The First Affiliated Hospital of the Air Force Medical University

Xi’an, Shanxi, 710032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Yang Yao

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

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: April 18, 2018
• First Posted: May 17, 2018
• Study Start: January 31, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

CN (6)