Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

Stopped early · Phase 3

Conditions studied: Dedifferentiated Liposarcoma

In brief

Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

Key facts

Study ID

NCT04979442

Run by

Rain Oncology Inc

People needed

175

Starts

2021-07-14

Expected to finish

2023-10-01

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed DD liposarcoma, with or without a WD component (WD/DD liposarcoma). Note: Patient must be willing to provide an archival tumor tissue sample that is ≤ 3 years old and of adequate quality or willing to provide a fresh pretreatment biopsy sample
• Advanced unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) and/or metastatic WD/DD liposarcoma
• Measurable tumor lesion(s) in accordance with RECIST version 1.1
• Received 1 or more systemic cancer therapy regimens, including at least 1 anthracycline-based regimen, and had radiographic progressive disease (per RECIST version 1.1) within 6 months before the Screening Visit
• Resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
• ECOG performance status of 0 or 1
• Adequate bone marrow function:
• Platelet count ≥ 100 × 10\^9/L
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count ≥ 1.5 × 10\^9/L
• Adequate hepatic function:
• Alanine aminotransferase and aspartate aminotransferase ≤ 3 × upper limit of normal (ULN) if no liver metastases are present; ≤ 5 × ULN if liver metastases are present
• Total bilirubin ≤ 1.5 × ULN, or ≤ 3 x ULN in the setting of Gilbert's disease

You may not qualify if…

• Prior treatment with any mouse double minute 2 (MDM2) inhibitor or trabectedin
• Other primary malignancies that have required systemic antineoplastic treatment within the previous 2 years, except for localized cancers that have apparently been cured
• Gastrointestinal conditions that could affect the absorption of milademetan, in the opinion of the Investigator
• Uncontrolled infection within the last 7 days requiring IV antibiotics, antivirals, or antifungals
• Known HIV infection or active Hepatitis B or C
• Untreated brain metastases. Note: Patients who require steroids for brain metastases must be on a stable or tapering dose of corticosteroids for at least 2 weeks before randomization. If applicable, patients must complete stereotactic radiosurgery 7 days before and whole brain radiotherapy 21 days before their first dose of study drug.
• Investigational therapy administered within the 28 days or 5 half lives:
• Cytochrome P450 3A4 isozyme strong inhibitor: 5 elimination half-lives
• CYP3A strong or moderate inducers: 4 weeks
• Systemic anticancer therapy or investigational therapy 3 weeks or 5 half-lives,
• Immunotherapy with checkpoint inhibitor: 4 weeks
• Curative-intent radiation therapy ≤ 4 weeks or palliative radiation therapy,
• Uncontrolled or significant cardiovascular disease:
• QTcF at rest, where the mean QTcF interval is > 480 milliseconds
• Myocardial infarction within 6 months
• Uncontrolled angina pectoris within 6 months
• New York Heart Association Class 3 or 4 congestive heart failure
• Uncontrolled hypertension

Where it is running

• Sarcoma Oncology Research Center, LLC — Santa Monica, California, United States
• UCLA Department of Medicine - Hematology/ Oncology — Santa Monica, California, United States
• CU Anschutz Medical Campus, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago Heights, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University School of Medicine, Duke Cancer Institute — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Abramson Cancer Center at Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Order Hospital Linz - Sisters of Mercy — Linz, Austria
• University Hospital Salzburg — Salzburg, Austria
• Medical University Vienna, Department of Internal Medicine I — Vienna, Austria
• Stanford Cancer Center — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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