Anlotinib for Alveolar Soft Part Sarcoma
(APROMISS Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Advenchen Laboratories, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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Exclusion Criteria

I do not have serious, uncontrolled infections.

I do not have any severe and uncontrolled diseases.

Untreated psychiatric disorders

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Treatment Details

Interventions

Anlotinib (Tyrosine Kinase Inhibitor)
Dacarbazine (Alkylating Agent)

Trial OverviewThe 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

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).