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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 : Unknown
Verified May 2021 by Ayala Pharmaceuticals, Inc,.
Recruitment status was:  Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ayala Pharmaceuticals, Inc,

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: AL101 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arms and Interventions
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Arm Intervention/treatment
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 intravenously

Other Name: BMS 906024


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 [ Time Frame: Up to 36 month ]

Secondary Outcome Measures :
  1. Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); [ Time Frame: Up to 36 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Ayala Pharmaceuticals, Inc,
More Information
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Responsible Party: Ayala Pharmaceuticals, Inc,
ClinicalTrials.gov Identifier: NCT03691207    
Other Study ID Numbers: AL-ACC-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma