A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma or Ewing-Like Sarcoma

  • STATUS
    Recruiting
  • End date
    Mar 2, 2024
  • participants needed
    24
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 4 October 2022

Summary

The purpose of this study is to find out whether LY2880070 combined with the chemotherapy drug gemcitabine is an effective treatment for Ewing sarcoma or Ewing-like sarcoma.

Details
Condition Ewing Sarcoma, Ewing-Like Sarcoma
Treatment Gemcitabine, LY2880070
Clinical Study IdentifierNCT05275426
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Consent/Assent: all patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Weight/Age: patients must be ≥40 kg at the time of study enrollment, but may be of any age
Diagnosis: Patients must have histologically documented locally advanced or metastatic disease confirmed at MSK as follows: ° Main cohort: Ewing sarcoma as molecularly defined by an EWSR1 fusion with an ETS-transcription factor family member including FLI1, ERG, ETV1, ETV4, and FEV
Note: Any patient being enrolled into the pilot cohort will be reviewed with study
pathologist, Dr. Cristina Antonescu, to ensure the categorization as Ewing-like sarcoma is
appropriate
Patients must be able to swallow capsules
Therapeutic options: patient's current disease state must be one which has failed
standard cytotoxic chemotherapy including cyclophosphamide/doxorubicin/vincristine and
ifosfamide/etoposide
Disease Status: patients must have measurable disease based on RECIST 1.1
Performance level: Karnofsky ≥70% for patients >16 years of age and Lansky ≥70 for
patients ≤16 years of age
Prior Therapy: patients may have had no more than 4 prior regimens (including
frontline therapy) and must meet the following minimum duration from prior anti-cancer
directed therapy prior to enrollment
Note: Patients who have previously received gemcitabine will be allowed unless they had
hypersensitivity or unacceptable toxicity attributed to gemcitabine
≥ 21 days must have elapsed after the last dose of cytotoxic or myelosuppressive
chemotherapy and patients must have recovered from the acute toxic effects of these
agents (other than alopecia)
≥ 14 days must have elapsed after radiation therapy, and toxicity related to prior
radiation therapy must be recovered to grade ≤ 1
≥ 21 days must have elapsed after the last dose of antibody therapy, and toxicity
related to prior antibody therapy must be recovered to grade ≤ 1
Organ Function Requirements
Adequate bone marrow function defined as
Absolute neutrophil count (ANC) ≥ 1500/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 8 g/dl
Adequate renal function defined as estimated glomerular filtration (eGFR) rate ≥ 60
mL/min/1.73m2
as estimated by CKD-EPI equation for patients ≥ 18 years of age OR
As estimated by cystatin C for patients < 18 years of age
Adequate liver function defined as
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal for
age
AST or ALT ≤ 2.5 x upper limit of normal for patients without liver metastases
AST or ALT ≤ 5 x upper limit of normal for patients with liver metastases
Serum albumin ≥ 2.5 g/dl
Adequate cardiac function defined as
Left ventricular ejection fraction (LVEF) >45% as measured on echocardiogram
cardiac MRI, or MUGA
QTc < 470 ms on screening 12 lead electrocardiogram
Pregnancy/Contraception
Post-menarchal females must have a negative urine or serum pregnancy test at
screening and ≤ 24 hours prior to study treatment
Males or females of reproductive potential must be willing to use a barrier
method of contraception throughout the course of the study and for 6 months after
completing study treatment

Exclusion Criteria

Patients for whom the investigator deems that gemcitabine is not appropriate
Patients who have an uncontrolled infection
Central Nervous System (CNS) Metastases
Patients who have symptomatic central nervous system (CNS) metastases. Note
patients with treated and asymptomatic CNS metastases are eligible
Patients with CNS metastases requiring corticosteroids for management
If the treatment of CNS disease requires anticonvulsants, the dose must have been
stable for ≥ 4 weeks
Patients who are pregnant or breast feeding
Patients who have a history of Torsades de Pointes, carry a diagnosis of congestive
heart failure, or have a family history of prolonged QT syndrome
Patients who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study
Patients with known hypersensitivity to gemcitabine
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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