Phase III Anlotinib and Catequentinib for Advanced Sarcoma (APROMISS)
This study, called APROMISS, is testing a drug called anlotinib (AL3818) for people with advanced alveolar soft part sarcoma (ASPS). Currently, only patients with ASPS can join. The study aims to see how well anlotinib works and how safe it is. For ASPS, all participants will receive anlotinib. The main goal for ASPS patients is to see how many experience a reduction in their tumor size (Objective Response Rate or ORR) over up to 48 months. This study is for adults aged 18 and older with unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) ASPS.
- Study design
- This is a Phase III interventional study. For participants with ASPS, it is an open-label study, meaning both you and your doctor will know you are receiving anlotinib. It plans to enroll 325 participants.
- What's involved
- Participants will take anlotinib orally once daily for 14 days, followed by 7 days off, in repeating 21-day cycles. The study duration for each patient is designed to end between Cycle 4, Day 18-21, with a total study duration of approximately 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- For ASPS, the Objective Response Rate is measured for up to 48 months. For other indications (now closed), Progression Free Survival was measured for up to 48 months. For Indication E, the whole study duration is approximately 12 months and no follow-up is planned.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
At a glance
Conditions
Where it's being run
24 sites across 17 statesStudy leadership
- Paul CEO · STUDY_DIRECTOR · Advenchen Laboratories, LLC
Who to contact
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What this trial measures
- Objective Response Rate (ORR) (ASPS)Up to 48 months
To determine ORR in subjects with ASPS, defined as percentage of subjects who achieve a Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1 as evaluated by a blinded independent radiological review (BICR).
- Progression Free Survival (PFS) (LMS/SS)From time of randomization to the date of disease progression or death from any cause, up to 48 months
To compare PFS in subjects with LMS or SS randomized to AL3818 versus dacarbazine, defined a median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs earlier as evaluated by a blinded independent radiologic review (BICR).
- Assess the ECG and the PK parameters of catequentinib hydrocoloride in probe substance (Indication E)Each patient study duration is designed to end between C4D18-D21 when the first RECIST and final visit are planned. Whole study duration is approximately 12 months and no any follow up is planned
To assess the ECGs and the PK parameters of catequentinib hydrocoloride in the administration of single-dose midazolam and single-dose of combined administration of P-gp and BCRP substrates digoxin and rosuvastatin in cancer patients.