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mTOR Inhibitor
Nab-Sirolimus + Letrozole for Endometrial Cancer
Phase 2
Recruiting
Research Sponsored by Aadi Bioscience, 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 24 months
Awards & highlights
Study Summary
This trial tests a combination of drugs to treat advanced or recurring endometrial cancer.
Who is the study for?
This trial is for adults with advanced or recurrent endometrioid endometrial cancer that can't be removed by surgery. Participants must have measurable cancer, acceptable organ function, and no severe infections or heart disease. They should not be pregnant, agree to use contraception, and cannot have certain other cancers or HIV/AIDS complications.Check my eligibility
What is being tested?
The study tests nab-Sirolimus combined with Letrozole in patients with a specific type of uterine cancer. It's an open-label Phase 2 trial where everyone gets the same treatment to see how effective it is at controlling the disease.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune suppression due to mTOR inhibition (like increased risk of infection), metabolic changes such as altered cholesterol and triglyceride levels, and possible interactions with other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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)
Secondary outcome measures
Disease Control Rate (DCR): CR or PR
Duration of response (DOR)
Incidence and severity
+3 moreSide effects data
From 2022 Phase 1 & 2 trial • 60 Patients • NCT0343946267%
Mucositis
58%
Fatigue
43%
Rash
38%
Diarrhea
37%
Myelosuppression (Thrombocytopenia)
35%
Nausea
30%
Myelossupression (Neutropenia)
28%
Hypertriglyceridemia
27%
Myelosuppression (Anemia)
27%
Weight decreased
25%
Decreased appetite
22%
Mucosal inflammation
18%
Hypokalemia
18%
Vomiting
18%
Lipase increased
18%
Dermatitis
17%
Dysgeusia
17%
Epistaxis
15%
Hyperglycemia
13%
Amylase increased
12%
Hypercholesterolemia
12%
Abdominal pain
10%
Headache
10%
Infection
10%
Hypophosphataemia
8%
ALT
8%
Anal inflammation
8%
Dry mouth
8%
AST
7%
Proctalgia
7%
Candida infection
7%
Hypoalbuminaemia
7%
Dehydration
5%
Hypomagnesaemia
5%
Nail disorder
5%
Dry eye
5%
Application site pain
5%
Dry skin
5%
Alopecia
5%
Gastrooesophageal reflux disease
5%
Oedema peripheral
5%
Dizziness
5%
Taste disorder
5%
Proteinuria
5%
Hypertension
5%
Anorexia
2%
Rectal perforation
2%
Enterocolitis infectious
2%
Pneumonia
2%
Colitis
2%
Stomatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4
Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4
Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4
Trial Design
1Treatment groups
Experimental Treatment
Group I: Endometrioid Endometrial CancerExperimental Treatment1 Intervention
Patients with advanced or recurrent endometrioid endometrial carcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-sirolimus
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Aadi Bioscience, Inc.Lead Sponsor
16 Previous Clinical Trials
512 Total Patients Enrolled
Willis Navarro, MDStudy DirectorAadi Bioscience
8 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Endometrial Cancer
32 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial cancer cannot be removed by surgery without severe risk.I have been treated with an mTOR inhibitor before.I have a tumor that can be measured by CT or MRI.My cancer is advanced or has come back and is a type called endometrioid endometrial carcinoma.My condition improved with previous treatments.My cancer has TSC1 or TSC2 alterations, and the PRECISION 1 study is open.I do not have a severe infection needing strong antibiotics now or in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrioid Endometrial Cancer
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential health risks do individuals with Endometrioid Endometrial Cancer face?
"While there is evidence for the safety of Endometrioid Endometrial cancer, efficacy has yet to be established. Thus, our team at Power rated this a 2 on their 1-3 scale."
Answered by AI
Is this experiment currently enrolling participants?
"According to clinicaltrials.gov, the recruitment process for this medical trial has concluded; it was first announced on December 1st 2023 and last updated August 10th 2023. However, there are still over four thousand other trials that are actively searching for volunteers."
Answered by AI
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