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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.

Must not have

Active or failed to control serious infections (CTCAE version 4.03 > grade 2 infections)

Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of sarcoma that cannot be surgically removed and has spread.

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I am fully active or can carry out light work.

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I have a confirmed diagnosis of advanced or metastatic alveolar soft part sarcoma that cannot be surgically removed.

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My synovial sarcoma cannot be removed by surgery and has come back or spread.

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My leiomyosarcoma cannot be removed by surgery and has spread.

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I have had at least one treatment for my LMS.

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My blood pressure is controlled and stable on my current medication.

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My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious, uncontrolled infections.

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I have not had extensive radiotherapy in the last 28 days or any radiotherapy in the last 14 days.

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I have a bleeding disorder like von Willebrand disease or hemophilia.

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I have a serious liver condition like cirrhosis or hepatitis needing treatment.

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I have not had serious bleeding like blood in urine, stool, or coughing up blood in the last 6 months.

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I haven't had severe bleeding or lung bleeding in the last month.

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I do not have any non-healing wounds or active ulcers.

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I do not have severe nerve damage in my hands or feet.

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I have heart issues but can still do physical activities without discomfort.

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I need dialysis for my kidney failure.

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My diabetes is not well-controlled (HgA1C >8).

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I have epilepsy that is not being treated or controlled.

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I have had an organ transplant.

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I can take pills without any issues like swallowing problems or chronic diarrhea.

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I have had or am allergic to dacarbazine.

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My lung tumor is near or touching major blood vessels.

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I am not pregnant or breastfeeding.

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I have been treated with anlotinib for LMS.

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I have had dacarbazine before or am allergic to it.

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I have ASPS and was previously treated with cediranib.

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I haven't had major surgery or significant injury in the last 28 days, nor minor surgery in the last 7 days.

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I am allergic to or have had a reaction to AL3818.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) (ASPS)

Progression Free Survival (PFS) (LMS/SS)

Secondary study objectives

Duration of Response (DOR) (ASPS)

Objective Response Rate (ORR) (LMS/SS)

Awards & Highlights

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

2005

Completed Phase 3

~5350

0 / 30Eligibility criteria met