Clinical Trial - NCT03691207

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

Recruiting

Sponsor: Ayala Pharmaceuticals, Inc,

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03691207

Protocol Info

Short Description: Phase 2 AL101 in Patients with ACC Bearing Activating Notch Mutations
Long Description: A Phase 2, Open-Label, Single-Arm, Multi-Center Study of AL101 (BMS-906024) in Patients with Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
MGH Status: Open
Sponsor: Ayala Pharmaceuticals, Inc
Disease Program: Head & Neck

Next Steps


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Purpose

This is a Phase 2, Simon 2-Stage optimal design, non comparative, open label, single-arm, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
Condition Title Intervention Phase
Adenoid Cystic Carcinoma AL101 Phase 2
Study Type Interventional
Official Title A Phase 2, Open-Label, Single-Arm, Multi-Center Study Of AL101 (BMS-906024) In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Primary Outcome Measures

Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 [Time Frame: Up to 36 month] [Designated as safety issue: ]


Secondary Outcome Measures

Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); [Time Frame: Up to 36 month] [Designated as safety issue: ]

Estimated Enrollment: 36
Study Start Date: December 2018
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: April 2021
Arms Assigned Interventions

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 intravenous.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly 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 in the past 2 years.

2. 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 ≤ 1.

7. Abnormal organ and marrow function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03691207

Locations

  • United States, California
    • USC Norris Comprehensive Cancer center Los Angeles, California, United States, 90033
  • United States, Florida
    • Sylvester Comprehensive Cancer Center Miami, Florida, United States, 33136
    • H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida, United States, 33612
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, New York
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, Texas
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Washington
    • Fred Hutchinson Cancer Research Center Seattle, Washington, United States, 98109
  • Canada, Alberta
    • Tom Baker Cancer Centre Calgary, Alberta, Canada, T2N 4N2
  • Canada, Ontario
    • Hamilton Health Sciences Juravinski Cancer Centre Hamilton, Ontario, Canada, L8V 1C3
    • London Health Sciences Center London, Ontario, Canada, N6A 5W9

Sponsors and Collaborators

Ayala Pharmaceuticals, Inc,

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03691207
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Adenoid Cystic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019