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Mdm2 Inhibitor

RAIN-32 for Liposarcoma (MANTRA Trial)

Phase 3
Waitlist Available
Research Sponsored by Rain Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) and/or metastatic WD/DD liposarcoma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

MANTRA Trial Summary

This trial is testing a new drug for people with a certain type of cancer that has progressed after trying other treatments. The trial will compare the new drug to a standard treatment to see if the new drug is more effective and has fewer side effects.

Eligible Conditions
  • Dedifferentiated Liposarcoma

MANTRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer called liposarcoma that cannot be surgically removed because it would cause too much harm. The cancer has also spread to other parts of your body.

MANTRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) between the milademetan treatment arm and trabectedin control arm
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Evaluate the patient-reported outcomes by using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (QLQ-C30)
+4 more

Side effects data

From 2008 Phase 2 trial • 271 Patients • NCT00060944
75%
Nausea
58%
Fatigue
55%
Alanine Aminotransferase Increased
49%
Neutropenia
48%
Aspartate Aminotransferase Increased
43%
Vomiting
35%
Constipation
32%
Anaemia
30%
Blood Alkaline Phosphatase Increased
28%
Headache
24%
Pyrexia
23%
Diarrhoea
22%
Anorexia
20%
Asthenia
19%
Thrombocytopenia
18%
Cough
16%
Dyspnoea
15%
Insomnia
14%
Back Pain
14%
Dizziness
13%
Myalgia
13%
Abdominal Pain
13%
Oedema Peripheral
13%
Arthralgia
12%
Leukopenia
12%
Neutrophil Count Decreased
12%
Upper Respiratory Tract Infection
11%
Blood Bilirubin Increased
11%
Blood Creatine Phosphokinase Increased
10%
Hypotension
10%
Hypokalaemia
10%
Pain in Extremity
10%
Dysgeusia
8%
Hypocalcaemia
8%
White Blood Cell Count Decreased
8%
Decreased Appetite
8%
Anxiety
7%
Dehydration
7%
Blood Creatinine Increased
7%
Haemoglobin Decreased
7%
Paraesthesia
7%
Depression
7%
Pruritus
6%
Abdominal Pain Upper
6%
Chills
6%
Pain
6%
Abdominal Distension
6%
Dyspepsia
6%
Hypoaesthesia
5%
Pneumonia
5%
Chest Pain
5%
Hyperglycaemia
5%
Hypoalbuminaemia
5%
Chest Wall Pain
5%
Platelet Count Decreased
5%
Transaminases Increased
5%
Weight Decreased
5%
Dyspnoea Exertional
5%
Rash
4%
Deep Vein Thrombosis
4%
Hyponatraemia
3%
Oedema
3%
Alopecia
2%
Intestinal Obstruction
2%
Renal Failure Acute
2%
Hypoxia
2%
Pneumothorax
2%
Pulmonary Hypertension
2%
Sarcoma Excision
2%
Thrombosis
2%
Atrial Fibrillation
2%
Catheter Related Infection
2%
Small Intestinal Obstruction
1%
Extravasation
1%
Bacteraemia
1%
Tachycardia
1%
Ventricular Tachycardia
1%
Ascites
1%
Sepsis
1%
Septic Shock
1%
Urosepsis
1%
Blood Urea Increased
1%
Tumour Haemorrhage
1%
Suicide Attempt
1%
Non-Cardiogenic Pulmonary Oedema
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Respiratory Failure
1%
Skin Ulcer
1%
Hepatic Embolisation
1%
Spinal Laminectomy
1%
Therapeutic Embolisation
1%
Tumour Excision
1%
Embolism
1%
Hypertension
1%
Shock
1%
Cholecystectomy
1%
Cardiac Failure Congestive
1%
Ileus
1%
Cerebral Haemorrhage
1%
Cardiomyopathy
1%
Mitral Valve Incompetence
1%
Abdominal Operation
1%
Bladder Catheterisation
1%
Empyema
1%
Infection
1%
Chest Discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trabectedin 1.5 mg/m2
Trabectedin 0.58 mg/m2

MANTRA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RAIN-32 (Milademetan)Experimental Treatment1 Intervention
260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle.
Group II: TrabectedinActive Control1 Intervention
1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks.

Find a Location

Who is running the clinical trial?

Rain Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
107 Total Patients Enrolled
Rain Oncology IncLead Sponsor
8 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Milademetan (Mdm2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04979442 — Phase 3
Liposarcoma Research Study Groups: RAIN-32 (Milademetan), Trabectedin
Liposarcoma Clinical Trial 2023: Milademetan Highlights & Side Effects. Trial Name: NCT04979442 — Phase 3
Milademetan (Mdm2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979442 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the recommended use for RAIN-32?

"RAIN-32 can be used to therapeutically target rna-binding protein fus, metastatic leiomyosarcoma, and metastatic liposarcoma."

Answered by AI

What other scientific papers have there been on RAIN-32?

"Currently, 18 RAIN-32 trials are ongoing and 2 of those are in Phase 3. The large majority of these clinical studies are taking place in Santa Monica, California; however, there are a total of 211 research sites for this RAIN-32."

Answered by AI

How many potential participants are being sought for this research project?

"As of right now, this clinical trial is not enrolling any more patients. The study was first posted on 7/14/2021 and was last edited on 8/4/2022. If you are looking for other studies, there are 46 trials for liposarcoma and 18 RAIN-32 trials that are still recruiting patients."

Answered by AI

Is RAIN-32 known to cause any serious side effects?

"There is some evidence of RAIN-32's efficacy, as well as multiple reports of its safety, so it has been given a score of 3."

Answered by AI

Where are the trial sites for this experiment?

"There are 23 recruiting sites for this clinical trial, with notable locations including H. Lee Moffitt Cancer Center & Research Institute in Tampa, North carolina, Duke University School of Medicine, Duke Cancer Institute in Durham, and University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center in Miami, Ohio."

Answered by AI
~48 spots leftby Mar 2025