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

Sponsor
Ayala Pharmaceuticals, Inc, (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03691207
Collaborator
(none)
87
Enrollment
17
Locations
1
Arm
47.6
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
87 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open labelOpen 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 :
Dec 14, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • BMS 906024

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 [Up to 36 month]

    Secondary Outcome Measures

    1. Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); [Up to 36 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC Norris Comprehensive Cancer center Los Angeles California United States 90033
    2 University of Colorado Cancer Center Aurora Colorado United States 80045
    3 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    4 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    5 University of Maryland School of Medicine Baltimore Maryland United States 21201
    6 Massachusetts General Hospital Boston Massachusetts United States 02114
    7 Mayo Clinic Hospital Rochester Minnesota United States 55902
    8 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    9 MD Anderson Cancer Center Houston Texas United States 77030
    10 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    11 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    12 Hamilton Health Sciences Juravinski Cancer Centre Hamilton Ontario Canada L8V 1C3
    13 London Health Sciences Center London Ontario Canada N6A 5W9
    14 Institut Gustave Roussy Villejuif France 94800
    15 Rabin Medical center Petah Tikva Israel 49100
    16 Radboud University Nijmegen Netherlands 6500
    17 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Ayala Pharmaceuticals, Inc,

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayala Pharmaceuticals, Inc,
    ClinicalTrials.gov Identifier:
    NCT03691207
    Other Study ID Numbers:
    • AL-ACC-01
    First Posted:
    Oct 1, 2018
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Adenoid Cystic

    Study Results

    No Results Posted as of Dec 14, 2021