Tyrosine Kinase Inhibitor
AL3818 for Soft Tissue Sarcoma
Washington University St. Louis, Saint Louis, MO
Targeting 4 different conditionsAL3818 +2 morePhase 3Waitlist AvailableResearch Sponsored by Advenchen Laboratories, LLCEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy of at least 3 months.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 48 months
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
Study Summary
This trial is currently recruiting patients with alveolar soft part sarcoma only and is no longer recruiting patients with synovial sarcoma or leiomyosarcoma.
Eligible Conditions
- Soft Tissue Sarcoma
- Leiomyosarcoma
- Alveolar Soft Part Sarcoma
- Synovial Sarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least three more months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) (ASPS)
Progression Free Survival (PFS) (LMS/SS)
Secondary outcome measures
Duration of Response (DOR) (ASPS)
Objective Response Rate (ORR) (LMS/SS)
Side effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Headache
19%
Dysphagia
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Dizziness/lightheadedness
9%
Rigors/chills
9%
Injection site reaction
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
8%
Dysphagia-esophageal radiation
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
1%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Indication C: SS AL3818 Arm - CLOSEDExperimental Treatment1 Intervention
Subjects with SS will be randomized in a 2:1 ratio to receive either AL3818 or IV dacarbazine. Subjects randomized to AL3818 will receive 12 mg AL3818 capsules orally once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Group II: Indication B: LMS AL3818 Arm - CLOSEDExperimental Treatment1 Intervention
Subjects with LMS will be randomized in a 2:1 ratio to receive either AL3818 or IV dacarbazine. Subjects randomized to AL3818 will receive 12 mg AL3818 capsules orally once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Group III: Indication A: ASPS AL3818 Arm - CLOSEDExperimental Treatment1 Intervention
All subjects with ASPS will be assigned to the open-label AL3818 arm to receive 12 mg AL3818 capsules orally once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Group IV: Indication C: SS Dacarbazine Arm - CLOSEDActive Control1 Intervention
Subjects with SS will be randomized in a 2:1 ratio to receive either AL3818 or IV dacarbazine. Subjects randomized to IV dacarbazine will receive dacarbazine at a dose of 1000 mg/m^2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle.
Group V: Indication B: LMS Dacarbazine Arm - CLOSEDActive Control1 Intervention
Subjects with LMS will be randomized in a 2:1 ratio to receive either AL3818 or IV dacarbazine. Subjects randomized to IV dacarbazine will receive dacarbazine at a dose of 1000 mg/m^2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle.
Group VI: Indication D: LMS AL3818 or Placebo Arm - CLOSEDPlacebo Group1 Intervention
Subjects with LMS will be randomized in a 2:1 ratio to receive either AL3818 or placebo in a double-blind manner. AL3818 or placebo will be administrated as one 12 mg capsule orally once daily in 21-day cycles for 14 days on treatment (Days 1-14) and 7 days off treatment (Days 15-21).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dacarbazine
FDA approved
Find a site
Who is running the clinical trial?
Advenchen Laboratories, LLCLead Sponsor
4 Previous Clinical Trials
338 Total Patients Enrolled
Paul CEOStudy Director
Advenchen Laboratories, LLCMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum dosage of AL3818 that has been shown to be safe for patients?
"Data from Phase 3 trials support the efficacy of AL3818 and because of this, as well as the fact that there are multiple rounds of data supporting safety, our team has given it a score of 3."
Answered by AI
Are there different research facilities across the United States conducting this same experiment?
"Patients are being enrolled at this time at the University of California Los Angeles, Stanford Medicine Cancer Institute, University of Michigan Comprehensive Cancer Center, and 16 other hospitals around the country."
Answered by AI
What are the primary indications for AL3818?
"AL3818 is the standard treatment for metastatic melanoma. Additionally, this medication can also improve quality of life for patients with adrenal medulla, advanced soft tissue sarcoma (sts), and pancreatic hormone conditions."
Answered by AI
How many people are receiving treatment as part of this clinical study?
"Unfortunately, this study is not enrolling patients at the moment. The listing was created on 2017-08-15 and edited for the last time on 2022-11-01. There may be other studies you're eligible for, as there are currently 475 trials for synovial sarcoma and 119 for AL3818 that are looking for participants."
Answered by AI
What is the previous experience with AL3818 in human trials?
"The first study evaluating AL3818 was conducted in 2002 at Canberra Hospital. 93 studies have completed since then. There are 119 active studies currently, a majority of which are enrolling patients in Los Angeles, California."
Answered by AI
Can new patients still join this research project?
"This study is no longer enrolling new patients. The clinical trial was first posted on 2017-08-15 and was last edited on 2022-11-01. However, there are presently 475 trials actively recruiting participants with synovial sarcoma and 119 studies for AL3818 actively searching for participants."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria