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Tyrosine Kinase Inhibitor
Anlotinib for Alveolar Soft Part Sarcoma (APROMISS Trial)
Phase 3
Waitlist Available
Research Sponsored by Advenchen Laboratories, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
APROMISS Trial Summary
This trial is currently recruiting patients with alveolar soft part sarcoma only and is no longer recruiting patients with synovial sarcoma or leiomyosarcoma.
Who is the study for?
Adults with advanced alveolar soft part sarcoma (ASPS) can join this trial. They may or may not have had previous treatments but must show disease progression. Key requirements include good organ function, no severe diseases, controlled blood pressure, and agreement to use contraception. Those with certain prior treatments or conditions like active brain metastases or recent major surgeries cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a drug called AL3818 (anlotinib) for ASPS compared to IV dacarbazine in leiomyosarcoma (LMS) or synovial sarcoma (SS), which are no longer being recruited. Two-thirds will receive anlotinib; one-third will get dacarbazine.See study design
What are the potential side effects?
Possible side effects of anlotinib include high blood pressure, bleeding risks, fatigue, and potential heart issues. Dacarbazine might cause nausea, vomiting, low blood cell counts leading to increased infection risk and tiredness.
APROMISS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of sarcoma that cannot be surgically removed and has spread.
Select...
I am fully active or can carry out light work.
Select...
I have a confirmed diagnosis of advanced or metastatic alveolar soft part sarcoma that cannot be surgically removed.
Select...
My synovial sarcoma cannot be removed by surgery and has come back or spread.
Select...
My leiomyosarcoma cannot be removed by surgery and has spread.
Select...
I have had at least one treatment for my LMS.
Select...
My blood pressure is controlled and stable on my current medication.
Select...
My kidney function is within the required range.
APROMISS Trial 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%
Dysphagia
19%
Headache
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%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
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%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
APROMISS 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
2005
Completed Phase 3
~5110
Find a Location
Who is running the clinical trial?
Advenchen Laboratories, LLCLead Sponsor
4 Previous Clinical Trials
362 Total Patients Enrolled
Paul CEOStudy DirectorAdvenchen Laboratories, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious, uncontrolled infections.I do not have any severe and uncontrolled diseases.My blood clotting tests are within normal limits, or I'm on blood thinners with no prior clotting issues.I received my last cancer treatment less than 3 weeks ago.I haven't had a different cancer than ASPS, LMS, or SS in the last 5 years, except for certain skin, bladder cancers or in situ carcinoma that were successfully treated.I have not had extensive radiotherapy in the last 28 days or any radiotherapy in the last 14 days.I have stable brain metastases and haven't used steroids in the last 7 days.My cancer is a type of sarcoma that cannot be surgically removed and has spread.I do not have any non-healing wounds or active ulcers.I have signed and understand the consent form for this study.I am 18 years old or older.I have a confirmed diagnosis of advanced or metastatic alveolar soft part sarcoma that cannot be surgically removed.My synovial sarcoma cannot be removed by surgery and has come back or spread.My leiomyosarcoma cannot be removed by surgery and has spread.My alkaline phosphatase levels are within the required range.My heart's pumping ability is good.I can take pills without any issues like swallowing problems or chronic diarrhea.I have a bleeding disorder like von Willebrand disease or hemophilia.I have a serious liver condition like cirrhosis or hepatitis needing treatment.I have had at least one standard treatment for my condition, including an anthracycline, unless I couldn't for health reasons or I chose not to.My cancer has worsened after the last treatment or I stopped treatment due to side effects within the last 6 months.I am fully active or can carry out light work.I have LMS and my previous treatments, including an anthracycline, didn't work.My cancer can be measured and has been confirmed by a scan within the last 28 days.I am using or willing to use birth control during and up to 3 months after the study.My blood, liver, and kidney tests are within normal ranges.I have not had serious bleeding like blood in urine, stool, or coughing up blood in the last 6 months.I haven't had severe bleeding or lung bleeding in the last month.I have had a deep vein clot in the last 6 months but have been on blood thinners for at least 14 days.I haven't taken more than 325 mg/day of aspirin in the last 10 days.I do not have severe nerve damage in my hands or feet.I have heart issues but can still do physical activities without discomfort.I need dialysis for my kidney failure.My diabetes is not well-controlled (HgA1C >8).I have epilepsy that is not being treated or controlled.I have had an organ transplant.I am not taking any strong medication that affects liver enzymes or those that can alter heart rhythm.My lung tumor is near or touching major blood vessels.I have had or am allergic to dacarbazine.I am not pregnant or breastfeeding.I have been treated with anlotinib for LMS.I have had dacarbazine before or am allergic to it.I have ASPS, regardless of my treatment history.I have ASPS and was previously treated with cediranib.I have had at least one treatment for my LMS.I don't have lasting side effects from past treatments, except for hair loss or mild nerve issues.My blood pressure is controlled and stable on my current medication.My kidney function is within the required range.I haven't had major surgery or significant injury in the last 28 days, nor minor surgery in the last 7 days.I am allergic to or have had a reaction to AL3818.I haven't had any major gut issues like perforations or abscesses in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Indication D: LMS AL3818 or Placebo Arm - CLOSED
- Group 2: Indication C: SS Dacarbazine Arm - CLOSED
- Group 3: Indication A: ASPS AL3818 Arm - CLOSED
- Group 4: Indication B: LMS AL3818 Arm - CLOSED
- Group 5: Indication B: LMS Dacarbazine Arm - CLOSED
- Group 6: Indication C: SS AL3818 Arm - CLOSED
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 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?
Met criteria
Did not meet criteria
What site did they apply to?
Mayo Clinic Arizona
MD Anderson Cancer Center
Why did patients apply to this trial?
I am looking for treattment options.
PatientReceived 1 prior treatment
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