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A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations (ACCURACY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03691207
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
Ayala Pharmaceuticals, Inc,

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: AL101 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arm Intervention/treatment
Experimental: SINGLE-ARM
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
Drug: AL101

AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane.

In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously

Other Name: BMS 906024

Primary Outcome Measures :
  1. Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 [ Time Frame: Up to 36 month ]

Secondary Outcome Measures :
  1. Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); [ Time Frame: Up to 36 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
  3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .
  4. Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03691207

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Contact: Gary Gordon, Dr. +1-857-444-0553

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United States, California
USC Norris Comprehensive Cancer center Recruiting
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Hamilton Health Sciences Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5W9
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Radboud University Recruiting
Nijmegen, Netherlands, 6500
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Ayala Pharmaceuticals, Inc,

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Responsible Party: Ayala Pharmaceuticals, Inc, Identifier: NCT03691207    
Other Study ID Numbers: AL-ACC-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type