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MDM2 Inhibitor
RAIN-32 for Pancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by Rain Oncology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose date to first cr, pr, or stable disease (sd) >= 16 weeks, or study completion date; up to 23.5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing milademetan, a medication for patients with advanced or metastatic solid tumors that haven't responded to other treatments. It targets specific genetic features in cancer cells to stop them from growing.
Eligible Conditions
- Stomach Cancer
- Pancreatic Cancer
- Bile Duct Cancer
- Cholangiocarcinoma
- Ovarian Cancer
- Adrenal Cortex Carcinoma
- Bladder Cancer
- Solid Tumors
- Adrenocortical Cancer
- Head and Neck Cancers
- Lung Adenocarcinoma
- Breast Cancer
- Melanoma
- Gene Amplification
- Testicular Cancer
- Cervical Cancer
- Non-Small Cell Lung Cancer
- Sarcoma
- Biliary Tract Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose date to first cr, pr, or stable disease (sd) >= 16 weeks, or study completion date; up to 23.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose date to first cr, pr, or stable disease (sd) >= 16 weeks, or study completion date; up to 23.5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To Determine the ORR of Treatment With Milademetan in Patients With Advanced/Metastatic Solid Tumors With MDM2 Gene Amplification.
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Growth Modulation Index (GMI)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Milademetan (RAIN-32)Experimental Treatment1 Intervention
260 mg once dailly orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
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Who is running the clinical trial?
Rain Oncology IncLead Sponsor
8 Previous Clinical Trials
279 Total Patients Enrolled
Rain Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition that is not well-managed or is serious.You have a gastrointestinal condition that could make it difficult for your body to absorb milademetan, according to the investigator.You have taken medication that targets a protein called MDM2 in the past.You have high blood pressure that is not well managed.You have received radiation therapy with the intent to cure within the last 4 weeks or received palliative radiation therapy.You have had severe chest pain (angina) that was not well managed within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Milademetan (RAIN-32)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT05012397 — Phase 2
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