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

Learn more about:
Related Clinical Trial
A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies Study of Everolimus (RAD001) in Combination With Lenalidomide MYPHISMO: MYB and PD-1 Immunotherapies Against Multiple Oncologies Trial Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC) Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC) Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma Dovitinib in Adenoid Cystic Carcinoma Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma Study of RAD001 in Adenoid Cystic Carcinoma

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

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

Administrative Informations


NCT ID

NCT03691207

Organization ID

AL-ACC-01


Responsible Party

Sponsor

Study Sponsor

Ayala Pharmaceuticals, Inc,


Study Sponsor

, , 


Verification Date

January 2020