Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80 or Lansky play-performance scale for pediatric patients ≥80
Patients must have 1 or more measurable target lesions by CT scan or MRI (RECIST v1.1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for patients with cancer who have a specific gene mutation.
Who is the study for?
Adults and adolescents (12+) with malignant solid tumors that can't be surgically removed or have spread, and have specific genetic changes in TSC1/TSC2 genes. They should have tried all standard treatments without success or not be suitable for them. Participants need to meet certain health criteria like good organ function, stable vital signs, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing nab-sirolimus on patients with advanced cancer who carry certain genetic alterations. It's an open-label study where everyone knows what treatment they're getting, aiming to see how effective this drug is against various types of solid tumors.See study design
What are the potential side effects?
While the exact side effects are not listed here, drugs similar to nab-sirolimus may cause issues like mouth sores, skin problems, increased risk of infections due to a weakened immune system, high blood sugar levels, lung problems such as pneumonitis or pulmonary hypertension.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am very active or mostly active with slight limitations.
Select...
I have at least one tumor that can be measured on a scan.
Select...
I am 12 years old or older.
Select...
My cancer has a specific genetic change in TSC1 or TSC2, found through advanced testing.
Select...
My kidneys work well enough (creatinine clearance ≥30 mL/min).
Select...
My cancer has spread and cannot be removed by surgery without severe complications.
Select...
I've had no major surgery or cancer treatment in the last 4 weeks and have recovered from any serious side effects.
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
Duration of response (DOR)
Incidence and severity of treatment-emergent and treatment-related adverse events (AEs)
+4 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
2Treatment groups
Experimental Treatment
Group I: Arm B: Pathogenic inactivating TSC2 alterationsExperimental Treatment1 Intervention
Patients with pathogenic inactivating TSC2 alterations.
Group II: Arm A: Pathogenic inactivating TSC1 alterationsExperimental Treatment1 Intervention
Patients with pathogenic inactivating TSC1 alterations.
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, LLCLead Sponsor
7 Previous Clinical Trials
192 Total Patients Enrolled
Aadi Bioscience, Inc.Lead Sponsor
16 Previous Clinical Trials
421 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is functioning within the required limits.I am very active or mostly active with slight limitations.My liver and kidney functions are within the required ranges.I have at least one tumor that can be measured on a scan.I am 12 years old or older.My blood counts and cholesterol levels are within the required ranges.I have tried all standard treatments for my cancer or cannot tolerate them.I am 12 years old or older.I am mostly active and can carry out daily activities without significant help.I agree to follow strict birth control measures during and after the study.I stopped taking medications that affect drug processing in my body 5 half-lives ago.I have a primary brain tumor or PEComa.I have brain complications from cancer, such as untreated or unstable brain metastases.I have had interstitial lung disease, pneumonitis, or pulmonary hypertension.I have been treated with an mTOR inhibitor before.I don't have any serious illnesses that could get worse with the study treatment.I have severe lung problems.My cancer has a specific genetic change in TSC1 or TSC2, found through advanced testing.I have tried all standard treatments for my cancer or cannot tolerate them.I have been cancer-free from any other cancer for over 5 years.I do not have recent serious heart issues or uncontrolled heart rhythm problems.My kidneys work well enough (creatinine clearance ≥30 mL/min).I am currently being treated for a severe infection or finished treatment less than a week ago.My cancer has spread and cannot be removed by surgery without severe complications.I've had no major surgery or cancer treatment in the last 4 weeks and have recovered from any serious side effects.My cancer has a specific genetic change in the TSC1 or TSC2 gene.I have at least one tumor that can be measured on a CT scan or MRI.I've had no major surgery or cancer treatment in the last 4 weeks and have recovered from any serious side effects.My cancer has spread and cannot be surgically removed without severe risk.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Pathogenic inactivating TSC2 alterations
- Group 2: Arm A: Pathogenic inactivating TSC1 alterations
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.
At how many hospitals is this clinical trial being conducted?
"Along with 74 other research facilities, this study is also being conducted at the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan, Cleveland Clinic in Cleveland, Ohio, and The University of Texas MD Anderson Cancer Center in Houston, Texas."
Answered by AI
How many test subjects are involved in this experiment?
"Yes, the information on clinicaltrials.gov says that this trial is actively recruiting participants. The clinical trial was first posted on 2/15/2022 and was most recently edited on 10/10/2022. The clinical trial is admitting 120 patients at 74 sites."
Answered by AI
Are there any other precedents for this kind of trial using nab-sirolimus?
"Nab-sirolimus is being studied in 130 different active clinical trials, with the majority of those studies being Phase 3 trials. The research for this medication is primarily based in Cincinnati, Ohio; however, there are 1084 total locations running these clinical trials."
Answered by AI
Are investigators still enrolling patients in this research project?
"The information on clinicaltrials.gov suggests that this trial is looking for patients at the moment. The study was originally put up on February 15th, 2022 and was last updated on October 10th, 2022."
Answered by AI
What are the conditions that nab-sirolimus is meant to address?
"Nab-sirolimus can help patients that have been affected by liver disease, kidney disease, and transplant rejection."
Answered by AI
Has the nab-sirolimus drug been federally sanctioned in the United States?
"Nab-sirolimus falls into the category of 'Phase 2' drugs, meaning that while there is some evidence indicating it is safe, none has been gathered to confirm its efficacy. Our team at Power estimates nab-sirolimus's safety to be a 2 on a scale from 1 to 3."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Cancer Specialists - North Division
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I need treatment ASAP!
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger