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

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 Status

Drug

Estimated Enrollment

87

Start Date

December 14, 2018

Completion Date

July 2021

Primary Completion Date

April 2021

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

, +1-857-444-0553, [email protected]

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT03691207

Organization ID

AL-ACC-01

Responsible Party

Sponsor

Study Sponsor

Ayala Pharmaceuticals, Inc,

Study Sponsor

, , 

Verification Date

January 2020