← Back to Search

Anti-metabolites

LY2880070 + Gemcitabine for Ewing Sarcoma

Q: How many participants are taking part in this investigation?

Indeed, according to clinicaltrials.gov, this medical study is currently recruiting patients who meet the criteria. This trial was initially posted on March 2nd 2022 and has since been updated on August 18th of the same year. 24 individuals need to be found across a single site for inclusion in this research project.

Q: Is this research endeavor presently recruiting participants?

Affirmative. Per the information available on clinicaltrials.gov, this research is actively seeking out suitable candidates and was initially published on March 2nd 2022 with a most recent update occurring August 18th 2022. The study requires 24 participants to be sourced from 1 location.

Q: What level of risk is associated with LY2880070 treatment?

Based on existing clinical data, LY2880070's safety was rated a 2 since this is an early phase trial that lacks efficacy-based evidence.

Phase 2

Recruiting

Led By Emily Slotkin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Therapeutic options: patient's current disease state must be one which has failed standard cytotoxic chemotherapy including cyclophosphamide/doxorubicin/vincristine and ifosfamide/etoposide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new drug combo to see if it's effective against Ewing sarcoma, a type of bone cancer.

Who is the study for?

This trial is for individuals of any age who weigh at least 40 kg and can swallow capsules. They must have Ewing sarcoma or similar, with measurable disease confirmed by specific molecular features. Participants need to be relatively healthy (Karnofsky ≥70% or Lansky ≥70), have adequate organ function, and no more than four prior cancer treatments. Pregnant individuals, those with certain heart conditions, uncontrolled infections, or hypersensitivity to gemcitabine are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of LY2880070 combined with chemotherapy drug gemcitabine in treating advanced Ewing sarcoma and related diseases. It aims to determine if this combination therapy can provide a new treatment option for patients who have not responded well to standard therapies.See study design

What are the potential side effects?

Potential side effects may include reactions typical of chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Specific side effects from LY2880070 are not detailed but could resemble other targeted cancer drugs' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer did not respond to standard chemotherapy treatments.

Select...

My cancer is a specific type called Ewing sarcoma, confirmed by a test.

Select...

My cancer can be measured using standard criteria.

Select...

I am mostly active and can care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best overall response rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ewing sarcomaExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,902 Total Patients Enrolled

Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

8 Previous Clinical Trials

534 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05275426 — Phase 2

Ewing Sarcoma Research Study Groups: Ewing sarcoma

Ewing Sarcoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05275426 — Phase 2

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05275426 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this investigation?

"Indeed, according to clinicaltrials.gov, this medical study is currently recruiting patients who meet the criteria. This trial was initially posted on March 2nd 2022 and has since been updated on August 18th of the same year. 24 individuals need to be found across a single site for inclusion in this research project."

Answered by AI

Is this research endeavor presently recruiting participants?

"Affirmative. Per the information available on clinicaltrials.gov, this research is actively seeking out suitable candidates and was initially published on March 2nd 2022 with a most recent update occurring August 18th 2022. The study requires 24 participants to be sourced from 1 location."

Answered by AI