Clinical Trials /

A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

NCT03691207

Description:

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.

Related Conditions:
  • Adenoid Cystic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AL-ACC-01
  • NCT ID: NCT03691207

Conditions

  • Adenoid Cystic Carcinoma

Interventions

DrugSynonymsArms
AL101BMS 906024SINGLE-ARM

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SINGLE-ARMExperimentalAL101 is an inhibitor of gamma secretase-mediated Notch signaling.
  • AL101

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1
Time Frame:Up to 36 month
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);
Time Frame:Up to 36 month
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ayala Pharmaceuticals, Inc,

Last Updated

December 29, 2019