Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)

Conditions

• Alveolar Soft Part Sarcoma
• Leiomyosarcoma
• Soft-Tissue Sarcoma
• Synovial Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AL3818 — DRUG
  Anlotinib (AL3818) 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)
• Dacarbazine — DRUG
  Dacarbazine 1000 mg/m2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle
• AL3818 or placebo — DRUG
  AL3818 or placebo 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)
• Midazolam 2 mg for CYP3A4 phenotyping — DRUG
  In indication E, midazolam will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of Cytochrome enzyme P450 3A4 (CYP3A4).
• Digoxin (0.25mg) — DRUG
  In indication E, Digoxin will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of P-glycoprotein.
• Rosuvastatin 10 mg tablet. — DRUG
  In indication E, Rosuvastatin will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of breast cancer resistance protein .

Study Details

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.

Key Dates

Start date

Aug 15, 2017

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

325 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Indication A: ASPS AL3818 Arm - CLOSED
  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).
• Experimental: Indication B: LMS AL3818 Arm - CLOSED
  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).
• Active Comparator: Indication B: LMS Dacarbazine Arm - CLOSED
  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.
• Experimental: Indication C: SS AL3818 Arm - CLOSED
  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).
• Experimental: Indication C: SS Dacarbazine Arm - CLOSED
  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.
• Placebo Comparator: Indication D: LMS AL3818 or Placebo Arm - CLOSED
  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).
• Active Comparator: Indication E: Catequentinib Hydrochloride (AL3818) Study of Concentration-QTc (C-QTc) and Drug-Drug
  This designed DDI study will assess how catequentinib hydrochloride affects the pharmacokinetics (PK) of midazolam (a known probe substrate of CYP3A4), Digoxin (a known probe substrate of P-gp) and rosuvastatin (a known probe substrate of BCRP) after the treatments of fourth cycles.

Primary Outcome Measure

Objective Response Rate (ORR) (ASPS) [ Time Frame: Up to 48 months ]

Central Contacts

• Shiying Clinical Trial Manager
  8055301550
  [email protected]
• Judy Clinical Trial Manager
  8055301550
  [email protected]

Locations (17)

Find similar trials in Phoenix, AZ

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