MDM2 Inhibitor

RAIN-32 for Bile Duct Cancer

Stanford University Medical Center, Palo Alto, CA
Targeting 18 different conditionsRAIN-32Phase 2Waitlist AvailableResearch Sponsored by Rain Oncology Inc

Study Summary

This trial is testing a new drug to see if it is safe and effective in patients with solid tumors that have not responded to other treatments.

Eligible Conditions
  • Bile Duct Cancer
  • Adrenocortical Cancer
  • Solid Tumors
  • Head and Neck Cancers
  • Lung Adenocarcinoma
  • Sarcoma
  • Bladder Cancer
  • Stomach Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Pancreatic Cancer
  • Gene Amplification
  • Testicular Cancer
  • Biliary Tract Cancer


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
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 criteria
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Growth Modulation Index (GMI)
+2 more

Awards & 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

Find a site

Who is running the clinical trial?

Rain Oncology IncLead Sponsor
7 Previous Clinical Trials
311 Total Patients Enrolled
Rain Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
227 Total Patients Enrolled

Media Library

Milademetan (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05012397 — Phase 2
Bile Duct Cancer Research Study Groups: Milademetan (RAIN-32)
Bile Duct Cancer Clinical Trial 2023: Milademetan Highlights & Side Effects. Trial Name: NCT05012397 — Phase 2
Milademetan (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012397 — Phase 2
Bile Duct Cancer Patient Testimony for trial: Trial Name: NCT05012397 — Phase 2

Frequently Asked Questions

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

Has the federal regulatory agency cleared RAIN-32 for public use?

"Our team at Power assigned RAIN-32 a score of 2 for safety on our scale, as the Phase 2 trial offers some assurance in its safety but does not yet have any data to back efficacy."

Answered by AI

How many US hospitals are carrying out this research protocol?

"This study is now looking for participants at 10 distinct medical sites, which are located in Saint Louis, Houston and Boston plus 7 other cities. To reduce the amount of travel you need to undertake if accepted into this trial, it would be prudent to opt for a site located close to you."

Answered by AI

Is this a pioneering endeavor in clinical trials?

"The first research on RAIN-32 was conducted in 2021 and sponsored by Rain Therapeutics Inc. After the completion of this initial study, which included 160 participants, it successfully gained Phase 3 drug approval. At present there are two ongoing trials for RAIN-32 being held across 32 cities and 15 countries worldwide."

Answered by AI

Can you provide any information on prior experiments related to RAIN-32?

"In 2021, the first RAIN-32 experiment was conducted at Leon Berard Center. Across 4 different trials to date, two of which are still in progress with a focus on Saint Louis, Missouri."

Answered by AI

How many participants are enrolled in the research currently?

"Affirmative. reveals that this clinical trial, which was originally published on November 1st 2021, is actively searching for volunteers. 65 participants are needed from 10 medical sites to complete the research objectives of this project."

Answered by AI

Are there any opportunities currently available to participate in this investigation?

"Affirmative. Referring to the information hosted on, it is evident that this medical experiment commenced recruiting subjects from November 1st 2021 and was recently updated in November 9th 2022 with a requirement for 65 participants across 10 sites."

Answered by AI

Who else is applying?

What state do they live in?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have been treated with gem/cis, and imfinzi and Zometa , and after only on imfinzi, Cancer has progressed. Looking for alternative treatment for cholangiocarcinoma tumor.

What questions have other patients asked about this trial?

What is involved in screening and how long does it take? When would I know something? What are qualifications? Does it involve mutations?
~20 spots leftby Aug 2024