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Ewing's Tumor MetastaticPhase 1/2NCT03416517

Anlotinib and Irinotecan for Ewing Sarcoma

A Phase 1/2 study testing Anlotinib and Irinotecan in people with Ewing's Tumor Metastatic, run by Peking University People's Hospital at 5 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma. Read more about this study

Who is it for?
Ages 5 to 65 years
Conditions the study is for
Ewing's Tumor Metastatic
What is being tested?
Anlotinib and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
5 sitesChina
Study dates
22 Jan 2018to Dec 2020
Phase
Phase 1/2
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 5 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed Ewing sarcoma.
  • Evidence of Ewing sarcoma translocation by fluorescence in situ hybridization (FISH) or real-time polymerase chain reaction (RT-PCT).
  • Recurrent or refractory tumors with no known curative treatment options according to the judgment of the investigator.
  • Prior treatment consisted of standard Ewing Sarcoma chemotherapy agents including doxorubicin, vincristine, cyclophosphamide, ifosfamide and etoposide; metastatic relapsed and unresectable progressive disease (PD);
  • Life expectancy of ≥ 3 months.
  • Eastern Cooperative Oncology Group performance status 0-1
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  • Measurable disease on CT or MRI by RECIST 1.1.
  • Adequate organ function.
  • Time elapsed from previous therapy must be ≥ 3 weeks for systemic therapy, ≥ 2 weeks for radiation therapy or major surgery.
  • Patients who have undergone autologous hematopoietic stem cell transplantation are eligible once they have recovered from all toxicities from therapy.
  • Patients who have received allogeneic hematopoietic stem cell transplantation will be eligible 6 months after the procedure provided there is no evidence of active graft-versus-host disease and immunosuppressive treatment has been discontinued for at least 30 days.
  • Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of central nervous system metastatic disease, have been off glucocorticoids for at least 4 weeks, have no overt evidence of neurological deficit and are ≥ 6 weeks from completion of brain irradiation.
  • Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication.

Who cannot join

  • Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the investigational agent or be likely to interfere with the study procedures or results.
  • Prior treatment consisted of anlotinib, any other antiangiogenic TKIs, or irinotecan.
  • Patients with baseline corrected QT interval(QTc) > 480 msec.
  • Known hypersensitivity reaction to anlotinib or any of its components, and irinotecan or any of its components.
  • Concomitant use of any other investigational or anticancer agent(s).
  • Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
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  • Inability to swallow capsules or water.
  • Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
  • Known persistent (> 4 weeks) ≥ Grade 2 neutropenia, ≥ Grade 2 thrombocytopenia or > Grade 3 anemia from prior cancer therapy.
  • Other kinds of malignant tumors at the same time.

Trial locations and contacts

5 sites in 1 country.

Wei Guo, M.D, Ph.D contact

86 010 88326152

bonetumor@163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Chuan Mi, M.D

    Not yet recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Jie Xu, M.D., 86 010 66583761, xujie_pkuph@sina.com

    Xin Sun, M.D., 86 010 66583761, xinsun1981@hotmail.com

    Recruiting

  • Peking University Shougang Hospital

    Beijing, 100144

    Lu Xie, M.D., 86 010 57830370, sweetdoctor@163.com

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Liang Jiang, M.D, jiangliang@bjmu.edu.cn

    Not yet recruiting

  • People's Liberation Army General Hospital

    Beijing, 100853

    Wenzhi Bi, M.D, biwenzhi@sina.com

    Not yet recruiting

Other trials in China

About this study

Official title: Anlotinib and Irinotecan for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy

The investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma.

Read the detailed description

After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades.Thus, the investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide.

Being tested
Anlotinib, Irinotecan
Keywords
Ewing Sarcoma, Anlotinib, Irinotecan, Refractory, Metastatic
Medical subject headings
Sarcoma, Ewing, Neoplasm Metastasis

What participants receive

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

  • AnlotinibDrug

    Also called AL3818

    Anlotinib 12 or 8 mg/d po D1-14 q3w

  • IrinotecanDrug

    Also called Camptosar

    Irinotecan 20 or 15mg/m^2/d IV over 60 minutes on days 1-5 and 8-12, q3w

Study groups in NCT03416517
Study groupRoleWhat they receive
Anlotinib and Irinotecan(phase 1b)ExperimentalAnlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15mg/m^2/d over 60 minutes on days 1-5 and 8-12 q3w. Vincristine 1.4mg/m^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Anlotinib; Drug: Irinotecan
Anlotinib and Irinotecan(phase 2)ExperimentalAnlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15 mg/m^2/d IV over 60 minutes on days 1-5 and 8-12 q3w. The final dose of anlotinib and irinotecan depends on the result from previous phase Ib study. Vincristine 1.4mg/m^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Anlotinib; Drug: Irinotecan

What is being measured

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

  1. Maximum tolerated dose (MTD) (phase 1b)

    evaluate the maximum tolerated dose (MTD) of combination therapy with irinotecan and anlotinib

    Measured: 12 months

  2. Object response rate(ORR) at 12 weeks (phase 2)

    complete response (CR) + partial response (PR) at 12 weeks

    Measured: 12 months

Secondary outcomes (5)

  1. Progression-free survival(PFS)

    Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.

    Measured: 2 years

  2. Overall survival(OS)

    Calculated from the date of treatment start until last follow-up or death, whichever comes first.

    Measured: 2 years

  3. Adverse Effect

    Adverse effect measured by CTCAE v.4 (Common Terminology Criteria for Adverse Events)

    Measured: 2 years

  4. Quality of Life (QoL)

    Quality of Life measured by EORTC QLQ(quality of life questionnair) C-30 for adults or PedsQL3.0 for children.

    Measured: 2 years

  5. Pain management

    Pain management measured by Visual Analog Score for pain.

    Measured: 2 years

Timeline

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

  1. First posted31 Jan 2018
  2. Study start22 Jan 2018
  3. Primary completionFeb 2020 (estimated)
  4. Study completionDec 2020 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416517
Sponsor's protocol ID
PKUPH-EWS-02
Status last verified
Feb 2019
First submitted
24 Jan 2018
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dong S, Sun K, Xie L, Xu J, Sun X, Ren T, Huang Y, Yang R, Tang X, Yang F, Gu J, Guo W. Quality of life and Q-TWiST were not adversely affected in Ewing sarcoma patients treated with combined anlotinib, irinotecan, and vincristine: (Peking University People's Hospital Ewing sarcoma trial-02, PKUPH-EWS-02). Medicine (Baltimore). 2021 Dec 23;100(51):e28078. doi: 10.1097/MD.0000000000028078.

    PubMed 34941047

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anlotinib and Irinotecan in people with Ewing's Tumor Metastatic, run by Peking University People's Hospital at 5 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 13 inclusion and 10 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Wei Guo, M.D, Ph.D (86 010 88326152, bonetumor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (phase 1b) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03416517, 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 15 Feb 2019.

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