Anlotinib for Alveolar Soft Part Sarcoma

(APROMISS Trial)

Not currently recruiting at 24 trial locations

Overseen By Judy Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Advenchen Laboratories, LLC

Must not be taking: Cediranib, Dacarbazine, Anlotinib, others

Disqualifiers: CNS metastases, Bleeding disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: Up to 48 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new drug, anlotinib, for treating metastatic or advanced alveolar soft part sarcoma (ASPS). Participants will receive anlotinib to determine its effectiveness in managing this specific cancer type. Ideal candidates for this trial have ASPS that cannot be surgically removed and may have already tried other treatments. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take certain medications that strongly affect liver enzymes or those that prolong the QT interval (a heart rhythm measure) within 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In previous studies, anlotinib has shown promise for treating advanced cancers like alveolar soft part sarcoma. Patients have generally tolerated it well, experiencing fewer negative side effects compared to some other cancer drugs.

Past research shows that dacarbazine has been used safely for various cancers, though it can cause side effects like nausea or low blood counts. As an older drug, there is extensive information about patient reactions.

Both treatments carry some risks, but studies suggest they are relatively safe when healthcare professionals monitor them. Always consult a doctor about potential side effects and what to expect during a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Anlotinib for treating alveolar soft part sarcoma (ASPS) because it works differently from traditional chemotherapy options like dacarbazine. Unlike conventional treatments that attack rapidly dividing cells, Anlotinib is a targeted therapy that inhibits specific proteins involved in tumor blood vessel formation, potentially slowing down cancer growth more precisely. This targeted approach might offer a more effective and less toxic alternative for patients with ASPS, making it a promising option in the fight against this rare cancer.

What evidence suggests that anlotinib might be an effective treatment for alveolar soft part sarcoma?

Studies have shown that anlotinib looks promising for treating alveolar soft part sarcoma (ASPS). Research indicates that anlotinib, a type of targeted therapy, is well tolerated and effective for ASPS. Patients have experienced better response rates and longer periods without disease progression when using anlotinib. In this trial, participants with ASPS will receive anlotinib. In contrast, dacarbazine has been used for various soft tissue sarcomas for a long time, but it is generally less effective and can cause more side effects, such as nausea and low white blood cell counts. Overall, anlotinib has shown more potential in treating ASPS compared to dacarbazine. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul CEO

Principal Investigator

Advenchen Laboratories, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Platelet count > 100,000 cells/mm3, hemoglobin > 9 g/dL, absolute neutrophil count > 1,500 cells/mm3

My blood clotting tests are within normal limits, or I'm on blood thinners with no prior clotting issues.

Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.

Exclusion Criteria

I do not have any severe and uncontrolled diseases.

I do not have serious, uncontrolled infections.

Untreated psychiatric disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AL3818 or IV dacarbazine in 21-day cycles until disease progression or unacceptable toxicity

Up to 48 months

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Anlotinib
• Dacarbazine

Trial Overview 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.

How Is the Trial Designed?

Group I: Indication C: SS AL3818 Arm - CLOSED Experimental Treatment 1 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 - CLOSED Experimental Treatment 1 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 - CLOSED Experimental Treatment 1 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 - CLOSED Active Control 1 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 - CLOSED Active Control 1 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 - CLOSED Placebo Group 1 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).

Who Is Running the Clinical Trial?

Advenchen Laboratories, LLC

Lead Sponsor

Trials

6

Recruited

850+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03016819?term=AREA%5BInterventionSearch%5D(AL-3818)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=1

Study Details | NCT03016819 | Phase III Trial of Anlotinib, ... APROMISS is a phase 3 study evaluating the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39453774/

Anlotinib plus TQB2450, a PD-L1 Antibody, in Patients with ... The combination of anlotinib and TQB2450 is effective and tolerable in patients with ASPS. TLS may serve as a prognostic biomarker, ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.11515

A phase II study of anlotinib and an anti-PDL1 antibody in ... The combination of anlotinib and TQB2450 exhibits promising efficacy in ASPS patients, markedly enhancing ORR and extending PFS with favorable tolerability.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7729354/

Target therapy for metastatic alveolar soft part sarcoma Anlotinib, another multi-receptor TKI, has been well tolerated in a phase II clinical trials for STS and shown to be highly effective in ASPS, ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/30/24/5577/750421/Anlotinib-plus-TQB2450-a-PD-L1-Antibody-in

Anlotinib plus TQB2450, a PD-L1 Antibody, in Patients with ... This study aimed to explore the efficacy and safety of anlotinib (a tyrosine kinase inhibitor) and TQB2450 (a PD-L1 inhibitor) in patients with ASPS.

6. aacrjournals.org aacrjournals.org/clincancerres/article/24/21/5233/281643/Safety-and-Efficacy-of-Anlotinib-a-Multikinase

Safety and Efficacy of Anlotinib, a Multikinase Angiogenesis ... Abstract. Purpose: The prognosis for patients with refractory soft-tissue sarcoma (STS) is dismal. Anlotinib has previously shown antitumor activity on.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12151220/

Safety and feasibility of anlotinib in children with high risk ... Anlotinib showed antitumour activity in several histologic types of STS, such as fibrosarcoma, alveolar soft-part sarcoma, liposarcoma, and ...