A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations (ACCURACY)
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|ClinicalTrials.gov Identifier: NCT03691207|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: AL101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 14, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
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.
Other Name: BMS 906024
- Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 [ Time Frame: Up to 36 month ]
- Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); [ Time Frame: Up to 36 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691207
|Contact: Andrea Vergara-Silva, Dr.||+1-857-444-0553||ClinicalTrials.gov_Accuracy@ayalapharma.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|