Brief Title
A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Official Title
A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1
Secondary Outcome
Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);
Condition
Adenoid Cystic Carcinoma
Intervention
AL101
Study Arms / Comparison Groups
SINGLE-ARM
Description: AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
87
Start Date
December 14, 2018
Completion Date
December 2022
Primary Completion Date
October 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03691207
Organization ID
AL-ACC-01
Responsible Party
Sponsor
Study Sponsor
Ayala Pharmaceuticals, Inc,
Study Sponsor
, ,
Verification Date
May 2021