RAIN-32 for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MD Anderson Cancer Center, Houston, TX
Tumors, Solid+1 More
RAIN-32 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether milademetan is safe and effective in people with advanced or metastatic solid tumors.

See full description

Eligible Conditions

  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether RAIN-32 will improve 1 primary outcome and 5 secondary outcomes in patients with Tumors, Solid. Measurement will happen over the course of 3 years.

3 years
Disease Control Rate (DCR)
Duration of Response (DOR)
Growth Modulation Index (GMI)
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
Overall Survival (OS)
Progression-free Survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

1 Treatment Group

Milademetan (RAIN-32)
1 of 1
Experimental Treatment

This trial requires 65 total participants across 1 different treatment group

This trial involves a single treatment. RAIN-32 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Milademetan (RAIN-32)
Drug
260 mg once dailly orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Closest Location

MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically and/or cytologically confirmed diagnosis of a cancer that is a locally advanced or metastatic solid tumor Measurable tumor lesion(s) in accordance with RECIST v1.1
Received all standard therapy appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard-of-care therapy
Resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
Platelet count ≥ 100 × 10^9/L
Hemoglobin ≥ 9.0 g/dL
Presence of WT TP53 and MDM2 gene amplification by tumor testing, defined as ≥ 12 copies by central diagnostic laboratory or ≥ 12 copies or 6-fold increase by local testing modalities
ECOG performance status of 0 or 1
Absolute neutrophil count ≥ 1.5 × 10^9/L
Adequate renal function
Creatinine clearance ≥ 30mL/min, as calculated using the modified Cockcroft-Gault equation

Patient Q&A Section

Can cancer be cured?

"This question is relevant to the medical profession as well as to patients who look for cancer cures. To be effective in reducing cancer mortality, treatment must be both effective and safe. A reasonable expectation of long-term survival is a prerequisite for successful cancer cure." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a generic disease that describes all of malignant conditions of the human body. The most common types of cancer are cancers of the breast, prostate, colon, rectum, and lung. Cancer is caused by the deregulation of cellular processes when cells become malignant. In the breast, most cases are breast cancer, which develops when breast tissue is stimulated by hormones, including estrogen and testosterone.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"As for any patient, all treatments for cancer cause unwanted side effects. Common treatment for cancer is surgery, chemotherapy, or radiation. Surgery can remove cancerous growths in a process called "localized therapy". Chemotherapy usually treats cancer by killing cancer cells using drugs, and radiation radiation therapy kills the cancer cells by damaging them physically. Other treatments include hormonal therapy to help control the symptoms of a tumor, or immunotherapy to fight the cancer, but these treatments often have substantial side effects. New cancer drugs and treatment protocols are developing to improve the quality of life of patients with cancer." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Cancer incidence trends in the US are similar to the trends reported for Europe. The incidence has increased from 1960 through 1975, and the proportion of individuals with cancer has increased, but this is not sufficient evidence that cancer incidence is increasing in the US." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Signs of cancer are usually detectable in patients older than 35 years. The symptoms of cancer can be subdivided in three groups: (1) asymptomatic, (2) systemic diseases or (3) symptoms of tumours. When a cancer is considered as an underlying cause of" - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Many, overlapping, environmental exposures can cause cancer through two processes: carcinogenesis (cancer initiation), and metastasis (cancer progression). Preventive measures can reduce cancers by reducing individual and environmental risks for causative hazards." - Anonymous Online Contributor

Unverified Answer

Does rain-32 improve quality of life for those with cancer?

"Rain-32 has an important and important effect on quality of life in patients who have cancer. It is a drug that can prevent the patients from dying from an unfavourable outcome of their illness, but when it comes to survival, Rain-32, unfortunately, does nothing." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving rain-32?

"The authors recommend that all studies of radiation treatments with low-energy-intensity beams utilize a full description of the beam's physical features, including energy and intensity distribution. Any attempt to standardize dosimetry with respect to beam characteristics or dose intensity needs to account for the fact that radiation treatment beam characteristics vary within the population." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"In the absence of evidence for efficacy, clinical trials are not recommended for those with localized cancer. A trial of a treatment of which there is anecdotal evidence of efficacy is recommended for those with distant or unresectable disease, who have undergone at least one previous surgical procedure, and those who are ineligible for a trial of chemotherapy, the benefit of which may not be known until several years after the surgery or the chemotherapy." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"Very serious and even life-threatening for most.  Yet people in India go against the odds and continue to live their full days, despite being affected." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"There is wide spread error in the estimation of ages at which cancer occurs (Figure 1). For example, in the United States, where all data are aggregated, the approximate average age when cancer occurs is 74." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Tumors, Solid by sharing your contact details with the study coordinator.