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Notch Inhibitor
AL101 Before Surgery for Adenoid Cystic Carcinoma
Phase 1
Recruiting
Led By Renata Ferrarotto
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance < 40 mL/min (Calculation of creatinine clearance [CrCl] will be based on acceptable institution standard)
Evidence of NOTCH1 pathway activation as determined by NICD1 IHC nuclear staining in >= 70% of tumor cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the effects of AL101 on patients with a specific type of cancer. AL101 may help to control the growth of cancer cells.
Who is the study for?
Adults with adenoid cystic carcinoma showing NOTCH1 pathway activation, who can consent to treatment and follow study rules. They must have a tumor that can be surgically removed and agree to use two forms of contraception if they're able to conceive. People with severe medical conditions, uncontrolled infections, or recent treatments for other cancers are excluded.Check my eligibility
What is being tested?
The trial is testing AL101's effectiveness when given before surgery in patients with notch activated adenoid cystic cancer. It aims to see if AL101 can halt tumor growth by inhibiting certain enzymes needed for cell proliferation.See study design
What are the potential side effects?
Possible side effects of AL101 may include reactions at the infusion site, increased risk of infection due to immune system suppression, liver enzyme alterations leading to potential liver damage, blood clotting issues such as bleeding diathesis or coagulopathy, and gastrointestinal disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is below 40 mL/min.
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My cancer shows high NOTCH1 activity.
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I am willing to have a biopsy to provide tumor samples.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My cancer is confirmed as adenoid cystic carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in NICD1 levels
Incidence of adverse events
Secondary outcome measures
Overall response rate
Side effects data
From 2022 Phase 2 trial • 87 Patients • NCT0369120779%
Diarrhoea
60%
Fatigue
45%
Nausea
43%
Hypophosphataemia
38%
Cough
33%
Epistaxis
31%
Dry mouth
31%
Vomiting
29%
Insomnia
29%
Decreased appetite
26%
Weight decreased
24%
Constipation
21%
Dysgeusia
19%
Dyspnoea
19%
Dermatitis acneiform
19%
Rash
17%
Stomatitis
17%
Dry skin
17%
Alopecia
17%
Asthenia
17%
Rash maculo-papular
14%
Hypokalaemia
12%
Hypocalcaemia
12%
Oropharyngeal pain
12%
Pruritus
12%
Dysphonia
12%
Mucosal inflammation
10%
Dehydration
10%
Aspartate aminotransferase increased
10%
Dyspepsia
10%
Pneumonia
10%
Dizziness
10%
Productive cough
10%
Oral pain
10%
Headache
10%
Back pain
10%
Dry eye
10%
Hypertension
10%
Hyperglycaemia
10%
Alanine aminotransferase increased
10%
Platelet count decreased
10%
Anaemia
7%
Abdominal pain upper
7%
Swelling face
7%
Gastrooesophageal reflux disease
7%
Arthralgia
7%
Neuralgia
7%
Neutrophil count increased
7%
Pyrexia
7%
Hypoxia
7%
Facial pain
7%
Oedema peripheral
7%
Infusion related reaction
7%
Dysphagia
7%
Candida infection
7%
Oral candidiasis
7%
Erythema
7%
Night sweats
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Vision blurred
7%
Urinary tract infection
5%
Cardiac arrest
5%
Pneumonia aspiration
5%
Anxiety
5%
Nasal dryness
5%
Skin lesion
5%
Depression
2%
Ejection fraction decreased
2%
Encephalopathy
2%
Musculoskeletal pain
2%
Sepsis
2%
Femoral neck fracture
2%
Abdominal pain
2%
Pneumonia pseudomonal
2%
Brain neoplasm
2%
Respiratory failure
2%
Eosinophilic pneumonia
2%
Brain cancer metastatic
2%
Clostridium difficile colitis
2%
Abdominal infection
2%
Acute respiratory distress syndrome
2%
Squamous cell carcinoma
2%
Vasculitis
2%
Bronchial obstruction
2%
Upper-airway cough syndrome
2%
Metastases to central nervous system
2%
Cellulitis
2%
Anorectal infection
2%
Streptococcal bacteraemia
2%
Drug-induced liver injury
2%
Haemoptysis
2%
Pleural effusion
2%
Pneumonitis
2%
Hepatobiliary disease
2%
Nasal congestion
2%
Hyponatraemia
2%
Pathological fracture
2%
Campylobacter sepsis
2%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - AL101 6mg
Cohort 1 - AL101 4mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AL101)Experimental Treatment2 Interventions
Patients receive AL101 IV over 60 minutes QW for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Within 24-72 hours after the last infusion of AL101, patients undergo surgery per standard of care. Patients may continue AL101 after surgery at the discretion of the study doctor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL101
2018
Completed Phase 2
~180
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,332 Total Patients Enrolled
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are capable of giving informed consent.You have had an allergic reaction or are allergic to the ingredients in the investigational product.My doctor believes my cancer can be surgically removed, either to try to cure it or to control its spread.I had cancer treatment at least 4 weeks ago for a local recurrence.My kidney function, measured by creatinine clearance, is below 40 mL/min.I have been treated with a gamma-secretase inhibitor before.I had cancer before, but it was treated, and I've been cancer-free for over 2 years.My cancer shows high NOTCH1 activity.I am willing to have a biopsy to provide tumor samples.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding.I agree to use contraception during and for 3 months after AL101 therapy.I have brain metastases but no current symptoms, or I've been treated and stable for at least 4 weeks.I am using two effective birth control methods while on and 90 days after AL101 therapy.I do not have ongoing stomach or bowel diseases that cause diarrhea.I am 18 years old or older.My cancer is confirmed as adenoid cystic carcinoma.I do not have a bleeding disorder that isn't managed by medication.I do not have an active infection needing treatment within the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AL101)
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.
Adenoid Cystic Carcinoma Patient Testimony for trial: Trial Name: NCT04973683 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential hazards associated with AL101 ingestion?
"There is minimal clinical data that supports the safety and efficacy of AL101, resulting in it receiving a score of 1."
Answered by AI
Is there presently an opportunity for patients to enroll in this trial?
"The records on clinicaltrials.gov indicate that this study is presently accepting applicants, with the first listing occurring on September 30th 2021 and a recent amendment posted October 31st 2022."
Answered by AI
How many participants are being enrolled in this research endeavor?
"Affirmative, the details on clinicaltrials.gov demonstrate that this clinical trial is presently in search of participants. It was initially published on September 30th 2021 and revised for the last time on October 31st 2022. 12 enrollees are needed from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Biopsy revealed basil cell carcinoma. Awaiting surgical procedure.
PatientReceived 2+ prior treatments
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