Mesylate Apatinib for Stage Ⅳ STS After Failure of Chemotherapy

NCT03121846 | Unknown Phase 2 DMC

• 1 other identifier: S201602
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective, Open-label, Single-Arm, Multi-center phase II clinical trial evaluating the efficacy and safety of Apatinib for Chemotherapy Failure Ⅳ Stage Soft Tissue Sarcoma.

Conditions

Soft Tissue Sarcoma, Adult, Stage II

Keywords

Apatinib; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

  2 year

Secondary Outcomes (4)

• Disease control rate(DCR）

  2 year

• Objective tumor response rate(ORR)

  2 year

• Overall survival(OS)

  3 year

• Adverse Events(AEs)

  2 year

Study Arms (1)

apatinib group

EXPERIMENTAL

apatinib 500mg po qd, 28 days for a cycle.

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Also known as: Apatinib Mesylate Tablets

apatinib group

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily join the study, signed informed consent, good compliance;
• The pathology was diagnosed as stage Ⅳ soft tissue sarcoma patients, clinical staging using the American Cancer Research Joint Committee (AJCC) TNM staging criteria. According to CT or MRI at least one measurable lesion;
• At least one chemotherapy regimen (containing anthracycline) was treated and evaluated as "disease progression" in terms of the efficacy evaluation criteria of solid tumors (RECIST 1.1).
• to 70 years old, PS score: 0 \~ 2; expected survival period of more than 3 months;
• The laboratory check meets the following criteria:
• Blood routine examination: HB ≥ 100g / L (14 days without blood transfusion); ANC ≥ 1.5 × 109 / L; PLT ≥ 80 × 109 / L
• Biochemical tests: serum creatinine Cr ≤ normal upper limit (ULN), bilirubin BIL ≤ normal upper limit (ULN), ALT, AST ≤ 1.5 × normal upper limit (ULN), for liver metastases ≤ 5 × normal upper limit (ULN); fasting triglyceride ≤ 3.0mmol / L, fasting cholesterol ≤ 7.75mmol / L;
• Doppler ultrasonography: left ventricular ejection fraction (LVEF) ≥ normal low (50%).
• Women should agree that contraceptive measures (such as IUDs, contraceptives or condoms) must be used within six months of the study period and after the end of the study; serum or urine pregnancy studies were negative for 7 days prior to study , and must be non-lactating patients; men should agree that contraceptive measures must be used within six months of the study period and after the end of the study period.

You may not qualify if:

• Patients who have received antiangiogenic therapy or other targeted treatment for no more than 3 months, such as Endostar, Erlotinib, Sunitinib, Sorafenib, Avastin, Imatinib, Famitinib, Pazopanib and other drugs.
• Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;
• Participated in other drug clinical researchers within four weeks;
• Previously received anticancer treatment patients with NCI CTC AE grade\> 1 grade toxicity;
• Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
• Known brain metastases, spinal cord compression, cancerous meningitis, or screening when the CT or MRI examination found that the brain or pia mater disease;
• Patients with any severe and / or uncontrolled disease, for example:
• Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrollable arrhythmia; poor blood pressure control (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg )patient;
• Active or uncontrollable serious infection;
• Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;
• Poor control of diabetes (fasting blood glucose (FBG)\> 10mmol / L);
• Urinary routine urinary protein ≥ ++, and confirmed 24 hours urine protein\> 1.0 g;
• Long untreated wound or fracture;
• Patients with bleeding tendency (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues;
• Interventional venous thrombosis events such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism before the first medication.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Zhejiang Cancer Hospital: collaborator
• Gansu Cancer Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Fudan University: collaborator

Study Sites (1)

Tianjin Medical University Cancer Hospital & Institute

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jilong Yang, M.D., Ph.D.

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Jilong Yang, M.D., Ph.D.

CONTACT

+8618622221626; yangjilong@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)