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Ewing SarcomaPhase 1NCT02044120

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

A Phase 1 study testing niraparib, Temozolomide and Irinotecan in people with Ewing Sarcoma, run by Sarcoma Alliance for Research through Collaboration at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide and/or irinotecan in patients with pre-treated incurable Ewing sarcoma. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Ewing Sarcoma
What is being tested?
niraparib, Temozolomide and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
5 sitesin 2 countries
Study dates
May 2014to Jan 2021
Phase
Phase 1
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 13 years and older
  • 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 FISH or RT-PCR.
  • Must be willing to undergo tumor biopsy at study entry for biologic correlates.
  • If patient > 18 years, must be willing to undergo on-treatment tumor biopsy unless medically contra-indicated
  • Recurrent or refractory tumors with no known curative treatment options according to the judgment of the investigator.
  • Age ≥ 13 years.
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  • Life expectancy of ≥ 3 months.
  • ECOG performance status 0-2.
  • Measurable disease on CT or MRI by RECIST 1.1.
  • Adequate organ function
  • Patients must have received as a minimum a first line chemotherapy regimen consisting of at least 2 of the following agents: doxorubicin, cyclophosphamide, ifosfamide, etoposide.
  • 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.
  • Patients or their legal representative (if the patient is < 18 years old) must be able to read, understand and provide written informed consent to participate in the trial.
  • 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.
  • Patients with baseline QTc > 480 msec.
  • Inability to swallow capsules.
  • Known hypersensitivity to any of the components of niraparib or prior hypersensitivity reactions to that class of drugs.
  • Known hypersensitivity reaction to temozolomide or any of its components, or dacarbazine (DTIC) if enrolled on ARM 1 or irinotecan or any of its components if enrolled on ARM 2
  • Concomitant use of any other investigational or anticancer agent(s).
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  • 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.
  • Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
  • Active central nervous system disease.
  • Known history of MDS or AML
  • Known persistent (> 4 weeks) ≥ Grade 2 neutropenia, ≥ Grade 2 thrombocytopenia or > Grade 3 anemia from prior cancer therapy

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of Michigan

    Ann Arbor, Michigan, 48106

  • National Cancer Institute

    Bethesda, Maryland, 20892

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

  • Seattle's Children Cancer Center

    Seattle, Washington, 98101

Other trials in United States

United Kingdom1 site

  • University College London Hospital

    London, W1T 7HA

Other trials in United Kingdom

About this study

Official title: ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan in Patients With Previously Treated,Incurable Ewing Sarcoma

The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide and/or irinotecan in patients with pre-treated incurable Ewing sarcoma.

Conditions
Ewing Sarcoma
Being tested
niraparib, Temozolomide, Irinotecan
Medical subject headings
Sarcoma, Ewing

What participants receive

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

Study groups in NCT02044120
Study groupRoleWhat they receive
niraparib and temozolomideExperimentalNiraparib (capsule) and temozolomide (capsule) will be taken together.
Receives: Drug: niraparib; Drug: Temozolomide
niraparib and irinotecanExperimentalNiraparib will be taken orally and irinotecan will be administered intravenously.
Receives: Drug: niraparib; Drug: Irinotecan
niraparib, irinotecan and temozolomideExperimentalNiraparib and temozolomide will be taken orally. Irinotecan will be administered intravenously.
Receives: Drug: niraparib; Drug: Temozolomide; Drug: Irinotecan

What is being measured

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

  1. Dose-limiting toxicity and maximum tolerated dose

    Dose limiting toxicity describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects.

    Measured: Approximately 24 months

Secondary outcomes (3)

  1. Tumor response rate

    The percentage of patients whose tumor shrinks or disappears after treatment

    Measured: Approximately 24 months

  2. Progression-free survival

    The time from starting treatment until disease progression

    Measured: Month 4 and 6

  3. Duration of response

    The time from tumor response to disease progression

    Measured: Approximately 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 Jan 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJan 2021
  4. Study completionJan 2021

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044120
Sponsor's protocol ID
ESP1/SARC025
Status last verified
Jan 2021
First submitted
21 Jan 2014
Last updated
12 Jan 2021
Results posted
No

Publications

  • Chugh R, Ballman KV, Helman LJ, Patel S, Whelan JS, Widemann B, Lu Y, Hawkins DS, Mascarenhas L, Glod JW, Ji J, Zhang Y, Reinke D, Strauss SJ. SARC025 arms 1 and 2: A phase 1 study of the poly(ADP-ribose) polymerase inhibitor niraparib with temozolomide or irinotecan in patients with advanced Ewing sarcoma. Cancer. 2021 Apr 15;127(8):1301-1310. doi: 10.1002/cncr.33349. Epub 2020 Dec 8.

    PubMed 33289920

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing niraparib, Temozolomide and Irinotecan in people with Ewing Sarcoma, run by Sarcoma Alliance for Research through Collaboration at 5 sites in 2 countries.

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 17 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jan 2021. 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 United States, United Kingdom. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicity and maximum tolerated dose (time frame: Approximately 24 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 NCT02044120, 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 12 Jan 2021.

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