Melanoma Clinical Trial

Milademetan in Advanced/Metastatic Solid Tumors

Summary

Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type (WT) TP53 and MDM2 copy number (CN) ≥ 12 using prespecified biomarker criteria.

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Full Description

Approximately 65 patients will be enrolled to receive milademetan.

Patients will receive the study drug until reaching unequivocal disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [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). Long-term follow-up will continue every 8 weeks (± 7 days) until the endpoint of death, the patient is lost to follow-up, or for 24 months following the final dose of the study drug, whichever comes first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically and/or cytologically confirmed diagnosis of a cancer that is a locally advanced or metastatic solid tumor
Measurable tumor lesion(s) in accordance with RECIST v1.1
Received all standard therapy appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard-of-care therapy
Resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
Presence of WT TP53 and MDM2 gene amplification by tumor testing, defined as ≥ 12 copies by central diagnostic laboratory or ≥ 12 copies or 6-fold increase by local testing modalities
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 renal function

Creatinine clearance ≥ 30mL/min, as calculated using the modified Cockcroft-Gault equation

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 a mouse double minute 2 (MDM2) inhibitor
Well-differentiated/dedifferentiated liposarcoma or intimal sarcoma
Primary malignancies that required systemic antineoplastic treatment within the previous 2 years, except for localized cancers that have apparently been cured
Primary brain tumor (e.g., glioma)
Untreated brain metastases
Gastrointestinal conditions that could affect the absorption of milademetan, in the opinion of the Investigator
Known HIV infection or active hepatitis B or C infection
Major surgery ≤ 3 weeks of the first dose of milademetan
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 2

Estimated Enrollment:

65

Study ID:

NCT05012397

Recruitment Status:

Recruiting

Sponsor:

Rain Therapeutics Inc.

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There are 10 Locations for this study

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Stanford University Medical Center
Palo Alto California, 94305, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Massachusetts General Hospital
Boston Massachusetts, 02214, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

65

Study ID:

NCT05012397

Recruitment Status:

Recruiting

Sponsor:


Rain Therapeutics Inc.

How clear is this clinincal trial information?

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