Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.

May 22, 2017 updated by: YaoWeitao, Henan Cancer Hospital
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The treatment of bone and soft tissue sarcomas are usually surgery and chemotherapy,advanced cases cannot be removed through surgical method for multiple metastasis,advanced cases Most advanced cases with chemotherapy is given priority to, but the effect is not ideal.Apatinib main through inhibit VEGFR to give play to Anti-angiogenesis effect to treatment of malignant tumor.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Jing Ding
          • Phone Number: 0371-65588251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject joined the study of his or her own free will , signed informed consent;
  2. Subject that diagnosed with advanced osteosarcoma by pathology and first-line treatment failure, at least have one measurable lesion ; Or confirmed by the pathology of advanced soft tissue sarcomas, at least have one measurable lesion,main include Synovial sarcoma、 Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、 Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma、Malignant peripheral nerve sheath tumor、Undifferentiatedsarcoma、 Rhabdomyosarcoma、chondrosarcoma、Osteosarcoma、Dermato- fibrosarcoma protuberans、GIST、Primitiveneuroectodermal tumor、Inflammatory myofibroblastic tumor、Malignant mesothelioma; 3)Within the past 6 months, Subject using at least one chemotherapy regimens (including anthracycline-based) failured (except gland alveolar soft tissue sarcoma); 4)18 to 70 years (including 18 and 70 ), men and women there is no limited. 5)ECOG PS score: 0 ~ 1; 6)Estimated survival period more than 3 months; 7)Main organs function within 7 days before the treatment, meet the following criteria:

    1. Blood routine examination standard( without blood transfusion condition in 14 days) :HB≥90g/L;②ANC≥1.5×109/L;③PLT≥80×109/L
    2. Blood biochemical examination must meet the following criteria:

      ① TBIL≤1.5ULN ;②ALT and AST≤2.5ULN,if With hepatic metastatic carcinoma,ALT and AST≤5ULN;③Cr≤1.5ULN或CCr≥60ml/min;

    3. Doppler ultrasound assessment: LVEF normal or low limit (50%).

      Exclusion Criteria:

      - 1)Subject with hypertension, and after antihypertensive drug therapy can't to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Ⅱ or higher level of coronary heart disease, arrhythmia (include QTc prolonging, male > 450 ms, female > 470 ms) and cardiac insufficiency; 2)Subject used targeted therapy of vascular endothelial growth inhibitor drug previous, include Sunitinib, Sorafenib ,bevacizumab, imatinib and so on.

      3)With other malignant tumor before or at the same time, but except the cured skin basal cell carcinoma and carcinoma in situ of cervix.

      4)Subject accepted anticancer therapy before with NCI CTCAE classification > 1 grade toxicity reaction.

      5)Has multi-factors that effect of oral drug absorption(, such as unable to swallow, nausea or vomiting, chronic diarrhea and intestinal obstruction, etc.); 6)Special note: subject with gastrointestinal bleeding risk can't enrolled the study, include: (1) there are active peptic ulcer lesions, and defecate occult blood (+ +);(2)Subject with medical history include Melena、hematemesis in three months;(3) Subject must be of gastroscopy with defecate occult blood, clear whether deposit organic gastrointestinal tract diseases; 7)Subject with coagulant function abnormality (INR > 1.5 x ULN, APTT > 1.5 x ULN), bleeding tendency; 8)Didn't heal wounds for a long time or fracture. 9)Subject with active bleeding or within 30 days after Major surgery. 10)Intracranial metastasis; 11)Pregnant or lactating women; 12)cell toxic drug therapy, radiation therapy 3 weeks after treatment; Once took two or more targeted drugs, or once took other targeted drugs 3 months before enrollment.

      13)Suffered from other malignant tumor for the past three years. 14)Investigator considered that there may be exist any situation that can damage subject or result in subject can't meet or carry out Investigator requests.

      15)huge transfer/recurrent lesions(tumor size greater than 5 cm). 16)malignant pleuraleffusion or peritoneal effusion, caused NCI CTCAE grading more than 2 levels of breathing difficulties; Description: oversized tumor load often indicates poor blood supply, lead to drug unable to effectively into the tumor, in order to accurately assess the treatment effects apatinib to the soft tissue sarcomas, Our study do not accept with huge transfer recurrent focal (tumor diameter greater than 5 cm) of the patients into groups temporarily .

      17)Allergy to any ingredient about apatinibshould be ruled out; 18)Subject with severe liver and renal failure (level 4) should be ruled out; 19)Subject has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 20)According to the investigator's judgment, subject who has concomitant diseases that serious to endanger the safety or impact subject to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Apatinib
Apatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) .
Apatinib 500mg,po,qd,medicine to disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress free survival
Time Frame: 6 months
time from study drug treatment to tumor progress
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to 24 months
Time from study drug treatment to die
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2017

Primary Completion (ANTICIPATED)

October 11, 2017

Study Completion (ANTICIPATED)

April 11, 2019

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • AHEAD-HNP007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Temporarily not sure whether to be Shared the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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