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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 : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ayala Pharmaceuticals, Inc,

Brief Summary:
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 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

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 intravenous.

Other Name: BMS 906024




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 ]


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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 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

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


Contacts
Contact: Andrea Vergara-Silva, Dr. +1-857-444-0553 ClinicalTrials.gov_Accuracy@ayalapharma.com

Sponsors and Collaborators
Ayala Pharmaceuticals, Inc,

Responsible Party: Ayala Pharmaceuticals, Inc,
ClinicalTrials.gov Identifier: NCT03691207     History of Changes
Other Study ID Numbers: AL-ACC-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma