A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor

NCT05275426 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 21-428
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ewing Sarcoma; Ewing-Like Sarcoma

Keywords

Ewing Sarcoma; Ewing-Like Sarcoma; LY2880070; Gemcitabine; 21-428; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Best overall response rate

  The ORR will include complete response and partial response (CR+PR) as defined using RECIST 1.1 criteria.

  6 months

Study Arms (1)

Ewing sarcoma

EXPERIMENTAL

Participants have a diagnosis of Ewing sarcoma as molecularly defined by an EWSR1 fusion with an ETS-transcription factor family member including FLI1, ERG, ETV1, ETV4, and FEV

Drug: LY2880070; Drug: Gemcitabine

Interventions

LY2880070 DRUG

Patients will receive treatment in 21-day cycles with LY2880070 50 mg twice daily orally on days 2-6, 9-13, and 16-20

Ewing sarcoma

Gemcitabine DRUG

Participants will receive treatment in 21-day cycles with gemcitabine 100 mg/m2 intravenously on days 1, 8 and optionally on day 15

Ewing sarcoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pilot cohort: Ewing-like sarcomas including CIC-rearranged sarcoma, BCOR-rearranged sarcoma, and sarcomas with a rearrangement between EWSR1 and a non-ETS family gene or desmoplastic small round cell tumor as molecularly defined by an EWSR1-WT1 fusion
• Note: Any patient being enrolled into the pilot cohort that does not have a CIC, BCOR- rearranged sarcoma, or desmoplastic small round cell tumor 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 any number of regimens 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Emily Slotkin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: March 2, 2022
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)