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Soft Tissue Sarcoma AdultPhase 2NCT03104335

Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial

A Phase 2 study testing Apatinib in people with Soft Tissue Sarcoma Adult and Advanced Cancer, run by Peking University People's Hospital at 3 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who experience progression after standard chemotherapy, have limited treatment options which promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly selective inhibitor of vascular endothelial… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Soft Tissue Sarcoma Adult, Advanced Cancer
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
0 participants
Where
3 sitesChina
Study dates
1 Apr 2017to 1 Mar 2020
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with a histologically and/or cytologically confirmed soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded) who are resistant / refractory to approved therapies or for whom no curative therapies are available.
  • All previous treatment (including surgery, radiotherapy and systemic anti-neoplastic therapy) must have been completed at least three weeks prior to study entry and any acute toxicities must have resolved.
  • Aged >/= 16 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of </= 2.
  • Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
  • Willing and able to comply with the protocol guidelines for the duration of the study.

Who cannot join

  • Unstable metastases to the central nervous system (CNS).
  • tumor embolus located at pulmonary vein.
  • Any of the following laboratory parameters: a) hemoglobin < 9 g/dL (5.6 mmol/L); b) neutrophils <1.5 x 109/L; c) platelets <100 x 109/L; d) serum bilirubin >25 µmol/L (1.5 mg/dL); e) liver function tests with values >3 x upper limit of normal (ULN) f) serum creatinine >1.5 x ULN or creatinine clearance < 60 mL/minute.
  • Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection
  • Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
  • Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis
Show all 18Show fewer
  • Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary only if INR>1.5 or prothrombin time（PT）>ULN+4s or activated partial thromboplastin time (APTT) >1.5 ULN.
  • Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within 1 week of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening
  • Proteinuria > 1+ on urine dipstick testing or 30 mg/dL
  • A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
  • Any treatment with investigational drugs within 30 days before the start of the study
  • Previous treatment with apatinib or other anti-angiogenesis tyrosine kinase inhibitors
  • receive CYP3A4 inhibitors within 7 days or CYP3A4 inducers within 12 days.
  • uncontrollable complicated diseases: such as infectious diseases, diabetes mellitus and so on.
  • Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection
  • Legal incapacity

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

Other trials in China

About this study

Official title: Apatinib for Advanced Soft Tissue Sarcoma Patients After Failure of Traditional Therapy: an One-armed, Phase 2, Open-label, Multicenter Prospective Trial

Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who experience progression after standard chemotherapy, have limited treatment options which promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option for heavily pretreated soft tissue sarcoma patients.

Read the detailed description

From April 1st 2017 to June 1st 2019, participants who met the following criteria were included: 1) histologically confirmed high-grade soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded); 2) initial treated in the orthopedic oncology departments of three affiliated hospitals of Peking University,including Peking University People's Hospital, Peking University Shougang Hospital and Peking University International Hospital; 3) not amenable to curative treatment; 4) multiple metastatic lesions which could not be cured by local therapy or unresectable local advanced lesions; 5) having measurable lesions according to Response Evaluation Criteria for Solid Tumors 1.1(RECIST 1.1); 6) expected to live longer than 3 months with an Eastern Cooperative Oncology Group performance status of 0 or 1 and acceptable hematologic, hepatic, and renal function; 7) needed to be verified refractory to doxorubicin and ifosfamide.

All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion, of which children patients' informed forms should be signed by their legal parents. Once the patient registered, he/she will be evaluated by his/her doctors of these departments at the clinic, and his/her follow-up should be done every eight weeks with at least chest CT as well as imaging of tumor lesions at other sites. A follow-up file should be sent every eight weeks to the coordination desk of these departments. This study was approved by the institutional review board, Peking University People's Hospital, Peking University Shougang Hospital and Peking University International Hospital Ethics Committee for Clinical Investigation, and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.

The investigators demand patients to use at least doxorubicin and ifosfamide. In a phase I trial, apatinib (Jiangsu Hengrui Medicine, Lianyungang, China) showed good oral bioavailability at a dose of 850 mg a day, the maximum-tolerated dose. Considering this, the participants are designed to receive 750 mg daily once oral administration of apatinib for body surface area (BSA) > 1.5 and 500mg daily for BSA <1.5. If the investigators meet with treatment interruptions because of grade 3 hematologic or grade 2 non-hematologic toxicities, dose reductions to 750 mg or 500 mg of apatinib per day, and supportive care should be allowed for the management of adverse events (AEs).

The primary objective is to describe the efficacy of apatinib in sarcoma patients. Endpoints is objective response rate (CR+PR) and Progression-Free-Survival (PFS) for each protocol as described containing apatinib according to RECIST 1.1. The secondary objective is overall survival (OS), duration of response (DR) and the characterization of toxicities. PFS is defined as the time from the start of using apatinib until disease progression or death, whichever occurs first. OS is defined as the time from the start of using apatinib until death. The period from appearance of response or stable disease to progression or death is thus considered the duration of response (DR).

Safety evaluation will be based on the frequency and severity of toxicities graded according to the Common Terminology Criteria for Adverse Events.

Being tested
Apatinib
Keywords
soft tissue sarcoma, advanced, apatinib, tyrosine-kinase inhibitors
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

    750 mg daily once oral administration of apatinib for body surface area (BSA) > 1.5 and 500mg daily for BSA <1.5. Half an hour after meal and everyday at the same time is usually advised.

Study groups in NCT03104335
Study groupRoleWhat they receive
Study armExperimentalevery participant will recieve 750 mg daily once oral administration of apatinib for body surface area (BSA) > 1.5 and 500mg daily for BSA <1.5. Half an hour after meal and everyday at the same time is usually advised.
Receives: Drug: Apatinib

What is being measured

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

  1. Objective Response Rate (ORR)

    the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number

    Measured: 4 months

Secondary outcomes (3)

  1. Duration of Response (DR)

    The period from appearance of response or stable disease to progression or death is thus considered the duration of response (DR).

    Measured: 4 months and 6 months

  2. Progression-Free Survival(PFS)

    PFS is defined as the time from the start of using apatinib until disease progression or death, whichever occurred first.

    Measured: 6 months

  3. Overall Survival(OS)

    OS is defined as the time from the start of using apatinib until death

    Measured: 12 months

Timeline

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

  1. First posted7 Apr 2017
  2. Study start1 Apr 2017
  3. Primary completion30 Jun 2019
  4. Study completion1 Mar 2020

Why it stopped: Not enough patients

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
Model description
participants will be advised to recieve 750 mg daily once apatinib for body surface area (BSA) \> 1.5 and 500mg daily for BSA \<1.5. Half an hour after meal and everyday at the same time is usually advised.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104335
Sponsor's protocol ID
PekingUAH-sarcoma070330
Status last verified
May 2020
First submitted
2 Apr 2017
Last updated
19 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jo VY, Doyle LA. Refinements in Sarcoma Classification in the Current 2013 World Health Organization Classification of Tumours of Soft Tissue and Bone. Surg Oncol Clin N Am. 2016 Oct;25(4):621-43. doi: 10.1016/j.soc.2016.05.001. Epub 2016 Jul 30.

    PubMed 27591490

  • Brodowicz T, Liegl-Atzwager B, Tresch E, Taieb S, Kramar A, Gruenwald V, Vanseymortier M, Clisant S, Blay JY, Le Cesne A, Penel N. Study protocol of REGOSARC trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase II trial. BMC Cancer. 2015 Mar 14;15:127. doi: 10.1186/s12885-015-1143-y.

    PubMed 25884155

  • Bains R, Magdum A, Bhat W, Roy A, Platt A, Stanley P. Soft tissue sarcoma - A review of presentation, management and outcomes in 110 patients. Surgeon. 2016 Jun;14(3):129-35. doi: 10.1016/j.surge.2014.06.002. Epub 2014 Sep 30.

    PubMed 25261278

  • Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

    PubMed 19451427

  • van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.

    PubMed 22595799

  • Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9.

    PubMed 27291997

  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

    PubMed 26884585

  • Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

    PubMed 23918952

  • Ding Q, Cheng X, Yang L, Zhang Q, Chen J, Li T, Shi H. PET/CT evaluation of response to chemotherapy in non-small cell lung cancer: PET response criteria in solid tumors (PERCIST) versus response evaluation criteria in solid tumors (RECIST). J Thorac Dis. 2014 Jun;6(6):677-83. doi: 10.3978/j.issn.2072-1439.2014.05.10.

    PubMed 24976990

  • Verger E, Salamero M, Conill C. Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur J Cancer. 1992;28A(8-9):1328-30. doi: 10.1016/0959-8049(92)90510-9.

    PubMed 1515244

  • Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529. doi: 10.1186/1471-2407-10-529.

    PubMed 20923544

  • Cirillo M, Venturini M, Ciccarelli L, Coati F, Bortolami O, Verlato G. Clinician versus nurse symptom reporting using the National Cancer Institute-Common Terminology Criteria for Adverse Events during chemotherapy: results of a comparison based on patient's self-reported questionnaire. Ann Oncol. 2009 Dec;20(12):1929-35. doi: 10.1093/annonc/mdp287. Epub 2009 Jul 17.

    PubMed 19622510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Soft Tissue Sarcoma Adult and Advanced Cancer, run by Peking University People's Hospital at 3 sites 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 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: withdrawn, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 4 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 NCT03104335, which also lists 12 linked publications.

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 19 May 2020.

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