CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
AL101drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691207
NCT03691207Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Ayala Pharmaceuticals, Inc,·interventional·Posted Oct 1, 2018·Updated Jan 31, 2024

In Brief

A Phase 2 clinical trial evaluating AL101 for Adenoid Cystic Carcinoma. Completed, enrolled 87 participants across 17 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenoid Cystic Carcinoma
CountriesCanada, France, Israel, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartDec 14, 2018
Primary CompletionJul 15, 2022
Study CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.8 years ago

Interventions

AL101drug

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