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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:December 14, 2018
End Date:July 2021
Contact:Andrea Vergara-Silva, Dr.
Email:ClinicalTrials.gov_Accuracy@ayalapharma.com
Phone:+1-857-444-0553

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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

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.


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
We found this trial at
6
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Calgary, Alberta
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Houston, Texas 77030
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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