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Osteosarcoma, AdvancedPhase 2NCT03163381

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

A Phase 2 study testing Apatinib in people with Osteosarcoma, Advanced, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Osteosarcoma, Advanced
What is being tested?
Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
11 Apr 2017to 11 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject joined the study of his or her own free will , signed informed consent;
  • 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:
  • Blood routine examination standard( without blood transfusion condition in 14 days) :HB≥90g/L;②ANC≥1.5×109/L;③PLT≥80×109/L
  • 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;
  • Doppler ultrasound assessment: LVEF normal or low limit (50%).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Weitao Yao contact

13298189535

ywtwhm@163.com

China1 site, 1 recruiting
  • Henan cancer hospital

    Zhengzhou, Henan, 450000

    Jing Ding, 0371-65588251

    Recruiting

Other trials in China

About this study

Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.

Read the 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.

Being tested
Apatinib
Keywords
first-line treatment failure, one measurable lesion
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Apatinib 500mg,po,qd,medicine to disease progression.

Study groups in NCT03163381
Study groupRoleWhat they receive
ApatinibExperimentalApatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) .
Receives: Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progress free survival

    time from study drug treatment to tumor progress

    Measured: 6 months

Secondary outcomes (1)
  1. overall survival

    Time from study drug treatment to die

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study start11 Apr 2017
  3. Primary completion11 Oct 2017 (estimated)
  4. Study completion11 Apr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03163381
Sponsor's protocol ID
AHEAD-HNP007
Status last verified
May 2017
First submitted
18 May 2017
Last updated
23 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Temporarily not sure whether to be Shared the data.

Publications

  • Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

    PubMed 31401903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Osteosarcoma, Advanced, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weitao Yao (13298189535, ywtwhm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progress free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03163381, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.

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