Milademetan in Advanced/Metastatic Solid Tumors

Status Terminated

Clinical Trial 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) ≥ 8 using prespecified biomarker criteria.

Clinical Trial 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 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 the study drug, whichever comes first. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Adenocarcinoma of Lung
Adrenocortical Carcinoma
Biliary Tract Cancer
Biliary Tract Neoplasms
Bladder Urothelial Carcinoma
Breast Cancer Invasive
Carcinoma
Cervical Cancer
Cholangiocarcinoma
Gastric Cancer
Head and Neck Carcinoma
Lung Adenocarcinoma
Melanoma
Neoplasms
Non Small Cell Lung Cancer
Ovarian Carcinoma
Pancreas Cancer
Pancreatic Neoplasms
Sarcoma
Solid Tumors
Stomach Adenocarcinoma
Testicular Germ Cell Tumor

Clinical Trial Details

NCT number	NCT05012397
Study type	Interventional
Source	Rain Oncology Inc
Contact
Status	Terminated
Phase	Phase 2
Start date	November 1, 2021
Completion date	October 15, 2023

View Details

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