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

Primary Purpose

Adenoid Cystic Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AL101
Sponsored by
Ayala Pharmaceuticals, Inc,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoid Cystic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Norris Comprehensive Cancer center
  • University of Colorado Cancer Center
  • Sylvester Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • University of Maryland School of Medicine
  • Massachusetts General Hospital
  • Mayo Clinic Hospital
  • Memorial Sloan Kettering Cancer Center
  • MD Anderson Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Tom Baker Cancer Centre
  • Hamilton Health Sciences Juravinski Cancer Centre
  • London Health Sciences Center
  • Institut Gustave Roussy
  • Rabin Medical center
  • Radboud University
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SINGLE-ARM

Arm Description

AL101 is an inhibitor of gamma secretase-mediated Notch signaling.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);

Full Information

First Posted
September 22, 2018
Last Updated
December 10, 2021
Sponsor
Ayala Pharmaceuticals, Inc,
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1. Study Identification

Unique Protocol Identification Number
NCT03691207
Brief Title
A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Acronym
ACCURACY
Official Title
A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ayala Pharmaceuticals, Inc,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Cystic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SINGLE-ARM
Arm Type
Experimental
Arm Description
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
Intervention Type
Drug
Intervention Name(s)
AL101
Other Intervention Name(s)
BMS 906024
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1
Time Frame
Up to 36 month
Secondary Outcome Measure Information:
Title
Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);
Time Frame
Up to 36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
USC Norris Comprehensive Cancer center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Hamilton Health Sciences Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Rabin Medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Radboud University
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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

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