A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations (ACCURACY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03691207|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : December 14, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: AL101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations|
|Actual Study Start Date :||December 14, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
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 intravenously
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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
- Patients must have Formalin-fixed, Paraffin-embedded tissue available .
- Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.
- Diagnosed with a malignancy other than ACC in the past 2 years.
- Uncontrolled, Active Infection
- Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
- Symptomatic central nervous system (CNS) metastases.
- Unstable or severe uncontrolled medical condition
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
- Abnormal organ and marrow function
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
|Responsible Party:||Ayala Pharmaceuticals, Inc,|
|Other Study ID Numbers:||
|First Posted:||October 1, 2018 Key Record Dates|
|Last Update Posted:||December 14, 2021|
|Last Verified:||May 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type