Study of Anlotinib in Patients With Primary Malignant Bone Tumors

A Single-Arm, Open-Label, Multicenter Clinical Trial With Anlotinib Hydrochloride Capsule for Primary Malignant Bone Tumors With Recurrence and Distant Metastases

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

Study Overview

• Status: Unknown
• Conditions: Neoplasm of Bone
• Intervention / Treatment: Drug: Anlotinib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100035
      • Beijing Jishuitan Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai No.6 People's Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • the First Affiliated Hospital of the Air Force Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anlotinib; Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Anlotinib; Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The time in which the group begins to cause death for any reason	through study completion, an average of 10 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: ALTN-15-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No