Anlotinib for Alveolar Soft Part Sarcoma

(APROMISS Trial)

Recruiting at 22 trial locations

Overseen By Judy Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Advenchen Laboratories, LLC

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

325 Participants Needed

Trial Summary

What is the purpose of this trial?

THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA. This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.

Research Team

Paul CEO

Principal Investigator

Advenchen Laboratories, LLC

Eligibility Criteria

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 serious, uncontrolled infections.

I do not have any severe and uncontrolled diseases.

Untreated psychiatric disorders

Timeline

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

Treatment Details

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.

Participant Groups

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+