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Clinical Trial 19814

Cancer Type: Head & Neck
Interventions:AL101; BMS-906024 (AL101)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Jameel Muzaffar

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

Objective

To assess the clinical activity of AL101(BMS-906024) using radiographic assessments and RECIST v1.1 in ACC patients with activating Notch mutations. To confirm safety and tolerability of AL101 in ACC patients with activating Notch mutations. To obtain a set of population parameters and to identify covariates that affect systemic exposure to AL101 and metabolite(s). To establish correlation between positive NICD1 stain and Notch1 mutations. To establish the correlation between mutations in Notch and associated genes and response or resistance to study drug.

Inclusion Criteria

  • 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 .Archived (within 3 years) or fresh core or punch needle biopsied are acceptable.
  • Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

  • Exclusion Criteria

  • Diagnosed with a malignancy in the past 2 years. Exceptions apply.
  • Evidence of uncontrolled active infection requiring systemic anti-bacterial, anti-viral or anti-fungal therapy 7 days or less prior to administration of study drug.
  • Gastrointestinal (GI) disease such as disorders with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)] Non-chronic conditions that are completely resolved for at least 2 weeks prior to starting study drug are not exclusionary.
  • Symptomatic central nervous system (CNS) metastases.
  • Unstable or severe uncontrolled medical condition
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Abnormal organ and marrow function