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mTOR Inhibitor
Nab-Sirolimus for Neuroendocrine Tumors
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
Minimum of 4 weeks since any major surgery, completion of radiation, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1
Adequate renal function: creatinine clearance ≥30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests a drug for NETs in the stomach, lung, & pancreas that haven't been treated before with mTOR inhibitors.
Who is the study for?
This trial is for adults with well-differentiated neuroendocrine tumors in the GI tract, lung, or pancreas. They should not have had prior mTOR inhibitor treatment and can have up to two other therapies (excluding somatostatin analogs). Participants need functioning major organs, controlled HIV if present, no severe medical conditions or recent surgeries, and must use effective contraception.Check my eligibility
What is being tested?
The study tests nab-sirolimus on patients who haven't used mTOR inhibitors before. It's a Phase 2 trial where all participants receive the same drug to see how it affects their cancer. The focus is on those with specific types of NETs that are advanced and cannot be surgically removed.See study design
What are the potential side effects?
While side effects specific to nab-sirolimus aren't listed here, common ones for similar drugs include mouth sores, skin issues like rash or acneiform dermatitis, fatigue, increased risk of infections due to immune suppression, high blood sugar levels, and possible lung problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It's been over 4 weeks since my last major surgery or radiation, and I've recovered from severe side effects.
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My kidneys work well enough (creatinine clearance ≥30 mL/min).
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I have HIV but no AIDS-related infections in the last year, my viral load is under control, and I'm not on strong CYP3A4 drugs.
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My blood counts meet the required levels for treatment.
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I am fully active or able to carry out light work.
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I am 18 years old or older.
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I have a specific type of cancer in my GI tract, lung, or pancreas and have had 2 or fewer treatments.
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
Efficacy of nab-sirolimus
Secondary outcome measures
Disease control rate
Duration of response
Incidence and severity of treatment
+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: neuroendocrine tumorsExperimental Treatment1 Intervention
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
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
520 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
5 Patients Enrolled for Neuroendocrine Tumors
Willis Navarro, MDStudy DirectorAadi Bioscience
8 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood triglyceride level must be below 300 mg/dL, and your cholesterol level must be 350 mg/dL or lower after fasting.My liver is functioning within the required limits for the trial.I have a progressing neuroendocrine tumor despite being on a stable somatostatin analog dose for 12 weeks or more.My tests show TSC1 or TSC2 gene changes.It's been over 4 weeks since my last major surgery or radiation, and I've recovered from severe side effects.My kidneys work well enough (creatinine clearance ≥30 mL/min).I have HIV but no AIDS-related infections in the last year, my viral load is under control, and I'm not on strong CYP3A4 drugs.My blood counts meet the required levels for treatment.I am fully active or able to carry out light work.I do not have severe health issues that could affect my participation in the study.Patients must have at least one visible and measurable tumor according to specific guidelines.I am currently being treated for a severe infection or finished treatment less than a week ago.I have a functional neuroendocrine tumor causing uncontrollable symptoms.I have previously been treated with mTOR inhibitors like nab-sirolimus.I am 18 years old or older.I am not taking any strong CYP3A4 inhibitors or inducers.I have a specific type of cancer in my GI tract, lung, or pancreas and have had 2 or fewer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: neuroendocrine tumors
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.
Are there any availabilities for participants in this research trial?
"Contrary to what is posted on clinicaltrials.gov, this medical trial has ceased recruitment currently as it was last updated in August 10th 2023. The initial posting of the study occurred at December 30th 2023. As an alternative, 3531 other trials are actively recruiting participants right now."
Answered by AI
Has the FDA approved therapies for neuroendocrine tumors?
"The team at Power has evaluated the safety of neuroendocrine tumors and provisionally given it a score of 2. This is due to Phase 2 trial data supporting its relative security, though there is still no evidence for efficacy."
Answered by AI
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