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Soft Tissue Sarcoma, Adult, Stage IIPhase 2NCT03121846

Mesylate Apatinib for Stage Ⅳ STS After Failure of Chemotherapy

A Phase 2 study testing Apatinib in people with Soft Tissue Sarcoma, Adult, Stage II, run by Tianjin Medical University Cancer Institute and 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Soft Tissue Sarcoma, Adult, Stage II
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 May 2017to 1 May 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

  • 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).
  • 18 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
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  • 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.

Who cannot join

  • 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;
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  • 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.
  • Have a history of psychiatric abuse and can not quit or have mental disorders;
  • Have a history of immunodeficiency, including HIV testing positive or other acquired, congenital immune deficiency disease, or a history of organ transplantation;
  • According to the researcher's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country.

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

+8618622221626

yangjilong@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Hospital & Institute

    Tianjin, Tianjin Municipality, 300060

    Jilong Yang, M.D., Ph.D., +8618622221626, yangjilong@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: Mesylate Apatinib for Stage Ⅳ Soft Tissue Sarcoma Patients After Failure of Traditional Chemotherapy: Prospective, Open-label, Single-Arm, Multi-center Phase II Clinical Trial

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.

Read the detailed description

The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year survival rate is lower than 10% reported in several large-scale studies. Although chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed to improve the response rates. Long-term using of cytotoxic drugs increased the risk of toxicity in patients. Apatinib is a small molecular inhibitor of Vascular Epithelial Growth Factor Receptor-2 (VEGFR-2). It has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in STS is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in stage IV sarcoma patients who failed in chemotherapy.

Being tested
Apatinib
Keywords
Apatinib, Soft Tissue Sarcoma
Medical subject headings
Sarcoma

What participants receive

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

  • ApatinibDrug

    Also called Apatinib Mesylate Tablets

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

Study groups in NCT03121846
Study groupRoleWhat they receive
apatinib groupExperimentalapatinib 500mg po qd, 28 days for a cycle.
Receives: Drug: Apatinib

What is being measured

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

  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.

    Measured: 2 year

Secondary outcomes (4)

  1. Disease control rate(DCR）

    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

    Measured: 2 year

  2. Objective tumor response rate(ORR)

    ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

    Measured: 2 year

  3. Overall survival(OS)

    OS is defined as the length of time from random assignment to death or to last contact.

    Measured: 3 year

  4. Adverse Events(AEs)

    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

    Measured: 2 year

Timeline

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

  1. First posted20 Apr 2017
  2. Study start1 May 2017
  3. Primary completion1 Nov 2018 (estimated)
  4. Study completion1 May 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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121846
Sponsor's protocol ID
S201602
Status last verified
Mar 2017
First submitted
17 Apr 2017
Last updated
22 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Soft Tissue Sarcoma, Adult, Stage II, run by Tianjin Medical University Cancer Institute and 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 9 inclusion and 18 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 22 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 Jilong Yang, M.D., Ph.D. (+8618622221626, yangjilong@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 2 year). 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 NCT03121846.

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 22 May 2017.

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