RecruitingPhase 3NCT03016819

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

A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

Sponsor

Advenchen Laboratories, LLC

Enrollment

325 participants

Start Date

Aug 15, 2017

Study Type

INTERVENTIONAL

Conditions

Leiomyosarcoma Synovial Sarcoma Alveolar Soft Part Sarcoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests two targeted drugs — anlotinib and catequentinib — in people with rare, hard-to-treat soft-tissue cancers (including sarcomas and other advanced solid tumors) to see if these medicines can shrink or control the disease. **You may be eligible if...** - You are 18 or older and have been diagnosed with an advanced or metastatic sarcoma (such as alveolar soft part sarcoma) or another solid tumor that has stopped responding to standard treatment - Your cancer can be measured on a scan - You are physically active enough to care for yourself (ECOG performance status 0 or 1) - Your heart, liver, kidneys, and blood counts are within acceptable ranges - You are willing to use reliable contraception during the study **You may NOT be eligible if...** - You have previously been treated with anlotinib or catequentinib (AL3818) - Your cancer has spread to the brain in an uncontrolled way - You have had serious bleeding, a major surgery, or radiation therapy within the past few weeks - You have uncontrolled high blood pressure, heart problems, serious infection, liver cirrhosis, or kidney failure requiring dialysis - You are pregnant or breastfeeding - You have had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAL3818

Anlotinib (AL3818) 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)

DRUGDacarbazine

Dacarbazine 1000 mg/m2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle

DRUGAL3818 or placebo

AL3818 or placebo 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)

DRUGMidazolam 2 mg for CYP3A4 phenotyping

In indication E, midazolam will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of Cytochrome enzyme P450 3A4 (CYP3A4).

DRUGDigoxin (0.25mg)

In indication E, Digoxin will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of P-glycoprotein.

DRUGRosuvastatin 10 mg tablet.

In indication E, Rosuvastatin will be used to see how catequentinib hydrochloride affects the pharmacokinetics (PK) of breast cancer resistance protein .

Locations(24)

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of California Los Angeles

Los Angeles, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

Stanford Medicine Cancer Institute

Stanford, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University St. Louis

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Thomas Jefferson Hospital - Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

UW Medicine-Seattle Cancer Care Alliance

Seattle, Washington, United States

Beijing Cancer Hospital

Beijing, China

Shanghai Sixth People's Hospital

Shanghai, China

Istituto Nazionale dei Tumori

Milan, Italy

University of Palermo

Palermo, Italy

University Campus Bio-Medico

Rome, Italy

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Royal Marsden Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03016819

Related Trials

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

NCT043328747 locations

Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma

NCT0754817715 locations

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas

NCT069752936 locations

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

NCT0608829097 locations

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1

NCT060838831 location