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2021-11-01
2023-10-15
2023-10-15
40
NCT05012397
Rain Oncology Inc
Rain Oncology Inc
INTERVENTIONAL
Milademetan in Advanced/Metastatic Solid Tumors
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-08-13 | 2024-08-16 | 2024-10-14 |
2021-08-13 | 2024-10-14 | 2024-10-17 |
2021-08-19 | 2024-10-17 | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Milademetan (RAIN-32) 260 mg once dailly orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle | DRUG: RAIN-32
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To Determine the ORR of Treatment With Milademetan in Patients With Advanced/Metastatic Solid Tumors With MDM2 Gene Amplification. | Overall Response Rate (ORR) of treatment with milademetan, as defined as the percentage of patients who have achieved confirmed complete response (CR) or Partial Response (PR) according to RECIST v1.1 | From first dose date to first confirmed complete or partial response or study completion date; up to 23.5 months. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR defined as the time from the date of first documentation of CR or PR according to RECIST v1.1 to the date of disease progression or death due to any cause according to Investigator assessment | From start date of response to first PD or study completion date; up to 23.5 months |
| Progression-free Survival (PFS) | PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment | From the first dose date to the earliest date of recurrence, progression, death, or study completion; up to 23.5 months |
| Growth Modulation Index (GMI) | GMI defined as the ratio of Time to Progression (TTP) with the nth line of therapy (TTPn; here defined as milademetan) to the most recent prior line of therapy (TTPn-1) | From the start date of the most recent prior line of therapy to the PD date on the study; up to 23.5 months |
| Disease Control Rate (DCR) | DCR defined as the percentage of patients with confirmed CR, PR, or stable disease (SD) for ≥ 16 weeks | From first dose date to first CR, PR, or stable disease (SD) >= 16 weeks, or study completion date; up to 23.5 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
