Melanoma Clinical Trial

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

Summary

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.

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Full Description

Approximately 160 patients will be randomly assigned in a 1:1 ratio to receive milademetan or trabectedin. Randomization will be stratified by the ECOG performance status (0 or 1) and number of prior treatments (≤ 2 or > 2) for the patient's liposarcoma.

Patients will receive study drug (i.e., milademetan or trabectedin) until reaching unequivocal disease progression (RECIST v.1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. Patients may be treated beyond tumor progression if they are experiencing clinical benefit based on the assessment of the Investigator in discussion with the Medical Monitor. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment information (i.e., date/duration of treatment, response, and subsequent disease progression). Long-term follow-up will continue every 12 weeks (± 7 days) until the endpoint of death, the patient is lost to follow-up, or for 24 months following the final dose of study drug, whichever comes first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

160

Study ID:

NCT04979442

Recruitment Status:

Active, not recruiting

Sponsor:

Rain Therapeutics Inc.

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There are 70 Locations for this study

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Stanford Cancer Center
Palo Alto California, 94304, United States
Sarcoma Oncology Research Center, LLC
Santa Monica California, 90403, United States
UCLA Department of Medicine - Hematology/ Oncology
Santa Monica California, 90404, United States
CU Anschutz Medical Campus, Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Northwestern Memorial Hospital
Chicago Heights Illinois, 60611, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Duke University School of Medicine, Duke Cancer Institute
Durham North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia Pennsylvania, 19106, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Order Hospital Linz - Sisters of Mercy
Linz , 4010, Austria
University Hospital Salzburg
Salzburg , 5020, Austria
Medical University Vienna, Department of Internal Medicine I
Vienna , 1090, Austria
Ghent University, Oncology Center
Ghent , 9000, Belgium
University Hospitals Leuven Campus Gasthuisberg
Leuven , 3000, Belgium
Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Georges-Francois Leclerc Cancer Research Center
Dijon Bourgogne-Franche-Comté, 21079, France
ICANS
Strasbourg Grand Est, 67000, France
Institut Bergonie
Bordeaux Nouvelle Aquitaine, 33076, France
Centre Hospitalier de Poitiers
Poitiers Nouvelle Aquitaine, 86021, France
Institute Claudius Regaud
Toulouse Occitanie, 31059, France
Centre Antoine Lacassagne
Nice Provence-Alpes-Côte d'Azur, 06189, France
CHU La Timone - Oncologie medicale
Marseille Prvence-Alpes-Cote d'Azu, 13005, France
Leon Berard Center
Lyon , 69003, France
Gustave Roussy
Villejuif , 94805, France
LTD High -Tech Hospital MedCenter
Batumi , 6000, Georgia
LLC Todua Clinica
Tbilisi , 0112, Georgia
LTD Health House
Tbilisi , 0144, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicin Center LLC
Tbilisi , 0172, Georgia
LTD Caucasus Medical Centre
Tbilisi , 0186, Georgia
Helios Hospital Bad Saarow, Clinic for Hematology, Oncology and Palliative Medicine
Bad Saarow Bradenburg, 15526, Germany
HELIOS Hospital Berlin-Buch
Berlin , 13125, Germany
University Medical Center-Mainz
Mainz , 55131, Germany
University Hospital Mannheim, Mannheim Cancer Center
Mannheim , 68167, Germany
Münster University Hospital
Münster , 48149, Germany
University Hospital Ulm
Ulm , 89081, Germany
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong , , Hong Kong
St Vincent's University Hospital
Dublin , D04 N, Ireland
National Cancer Institute, IRCCS
Milan , 20133, Italy
National Cancer Institute-IRCCS "Fondazione G. Pascale"
Naples , 80131, Italy
Veneto Oncology Institute (IOV), IRCCS
Padova , 35128, Italy
University Polyclinic Hospital "Paolo Giaccone" Palermo
Palermo , 90127, Italy
Santo Stefano Hospital of Prato - USL Company Toscana Center
Prato , 59100, Italy
Santo Stefano Hospital - ASL 4 Toscana
Prato , ASL4, Italy
University Hospital Campus Bio-Medico
Rome , 00128, Italy
Institute of Cancer Research and Treatment of Candiolo - IRCCS
Turin , 10060, Italy
Severance Hospital, Yonsei University Health System Seoul
Seoul , 03722, Korea, Republic of
Asan Medical Center, Department of Oncology
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
M. Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma
Warsaw , 02-78, Poland
Passeig de la Vall d'Hebron 119-129
Barcelona , 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
University General Hospital Gregorio Marañon
Madrid , 28009, Spain
University Hospital Foundation Jimenez Diaz
Madrid , 28040, Spain
University Hospital Miguel Servet
Zaragoza , 50009, Spain
National Taiwan University Hospital
Taipei , 10022, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
The Royal Marsden Hospital NHS Foundation Trust
London Chelsea, SW3 6, United Kingdom
The Christie NHS Foundation Trust, Department of Medical Oncology
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

160

Study ID:

NCT04979442

Recruitment Status:

Active, not recruiting

Sponsor:


Rain Therapeutics Inc.

How clear is this clinincal trial information?

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