A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Completed · Phase 2

Conditions studied: Adenoid Cystic Carcinoma

In brief

This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

Key facts

Study ID

NCT03691207

Run by

Ayala Pharmaceuticals, Inc,

People needed

87

Starts

2018-12-14

Expected to finish

2022-12-02

Last updated by the study team

2024-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
• Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
• Patients must have Formalin-fixed, Paraffin-embedded tissue available .
• Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

You may not qualify if…

• Diagnosed with a malignancy other than ACC in the past 2 years.
• Uncontrolled, Active Infection
• Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
• Symptomatic central nervous system (CNS) metastases.
• Unstable or severe uncontrolled medical condition
• Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
• Abnormal organ and marrow function

Where it is running

• USC Norris Comprehensive Cancer center — Los Angeles, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic Hospital — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Hamilton Health Sciences Juravinski Cancer Centre — Hamilton, Ontario, Canada
• London Health Sciences Center — London, Ontario, Canada
• Institut Gustave Roussy — Villejuif, France
• Rabin Medical center — Petah Tikva, Israel
• Radboud University — Nijmegen, Netherlands
• The Christie NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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