Trials / Terminated
TerminatedNCT05012397
Milademetan in Advanced/Metastatic Solid Tumors
A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors (MANTRA-2)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Rain Oncology Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Solid Tumors
- Head and Neck Carcinoma
- Cholangiocarcinoma
- Sarcoma
- Lung Adenocarcinoma
- Bladder Urothelial Carcinoma
- Stomach Adenocarcinoma
- Breast Cancer Invasive
- Ovarian Carcinoma
- Cervical Cancer
- Non Small Cell Lung Cancer
- Gastric Cancer
- Biliary Tract Cancer
- Melanoma
- Pancreas Cancer
- MDM2 Gene Amplification
- Testicular Germ Cell Tumor
- Adrenocortical Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RAIN-32 | 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2023-10-15
- Completion
- 2023-10-15
- First posted
- 2021-08-19
- Last updated
- 2024-10-17
- Results posted
- 2024-10-17
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05012397. Inclusion in this directory is not an endorsement.