Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental drug combo for rare sarcoma shows promise, but trial halted early

NCT ID NCT05712694

Disease control Sponsor: Polaris Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding ADI-PEG 20 to standard chemotherapy (gemcitabine and docetaxel) could help people with advanced leiomyosarcoma, a rare soft tissue cancer. The study planned to enroll 218 participants whose cancer had progressed after prior treatment. Unfortunately, the trial was terminated early, so it is not yet known if the combination improves outcomes. The results may still provide clues for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ADI-PEG 20 (pegargiminase) plus gemcitabine and docetaxel
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced leiomyosarcoma that has stopped responding to standard therapy.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if ADI-PEG 20 adds benefit over chemotherapy alone, and side effects from the drug combination may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

218 people

The number who actually took part.

Started

Nov 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A subject will be eligible for study participation if he/she meets the following criteria: 1. Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc. 2. Determination of LMS subtype: uterine or non-uterine. 3. Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam. 4. Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin. 5. Treatment \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed. 6. Age \>18 years. 7. Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 at enrollment (Appendix B). 8. Leukocytes ≥ 3,000/mcL. 9. Absolute neutrophil count ≥ 1,500/mcL. 10. Platelets ≥ 100,000/mcL. 11. Hemoglobin ≥ 8.0 g/dL 12. Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease) 13. AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present) 14. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation). 15. Serum uric acid ≤ 8 mg/dL (with or without medication control). 16. QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women. 17. Subjects and their partners must be asked to use appropriate contraception. They must agree to use 2 forms of contraception or agree to refrain from intercourse for the duration of the study and for 35 days after the last dose of ADI-PEG 20 or for at least 3 months (male subjects) or 6 months (female subjects) after treatment with gemcitabine, whichever is the longer duration. 18. Ability to understand and willingness to sign the informed consent form. 19. No concurrent investigational drug studies are allowed. Exclusion Criteria: * A subject will not be eligible for study participation if he/she meets any of the exclusion criteria: 1. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of current diagnosis. 2. Currently receiving chemotherapy, immunotherapy, interferon, radiation therapy or other investigational agents. Note: Chemotherapy agent washout period is 5 half-lives prior to randomization. Radiation washout period is 7 days prior to randomization. 3. Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled. 4. Prior pelvic radiation. 5. Known brain metastases. Such patients must be excluded from this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated compounds, or other agents used in this study. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. History of seizure disorder not related to underlying cancer. 9. Grade 2 or higher neuropathy. 10. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. 11. Known HIV-positivity. Because of the potential for pharmacokinetic interactions of antiretroviral therapy with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. 12. Currently receiving other immunosuppressive agents. 13. Subjects under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Soft tissue sarcoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

leiomyosarcoma sarcoma soft tissue sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Soft tissue sarcoma

Contacts and locations

Locations

  • Chang Gung Medical Foundation Kaohsiung

    Kaohsiung City, Niaosong District, 83301, Taiwan

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Mass General Brigham Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre (Quebec)

    Montreal, Quebec, H4A 311, Canada

  • Medical College of Wisconsin/ Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • National Taiwan University Hospital

    Taipei, Taipei, 10002, Taiwan

  • Northwestern

    Chicago, Illinois, 60611, United States

  • Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210, United States

  • Stanford University Medical Centre

    Palo Alto, California, 94304, United States

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • UCLA

    Santa Monica, California, 90404, United States

  • UCSF

    San Francisco, California, 94158, United States

  • UHN - Princess Margaret Cancer Center (Ontario)

    Toronto, Ontario, M5G 2M9, Canada

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UPenn (Abramson Cancer Center, Pennsylvania Hospital)

    Philadelphia, Pennsylvania, 19106, United States

  • USC Norris comprehensive cancer center

    Los Angeles, California, 90033, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Colorado Cancer Center/ CU Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Miami/ Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.