MOLECULARLY TARGETED: ALK alteration: METASTATIC: >/= 2nd Line: "MY PATHWAY- ALK"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Title
Genetech ML28897 ALK
Study Title

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Site Link
Malignancy
Ovarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or greater
Investigational Agent
Alectinib
Drug Class
ALK inhibitor
PI
Ari VanderWalde
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic solid tumor
  • ALK alterations as follows
    • ALK gene rearrangements by NGS or FISH using Vysis ALK Break Apart FISH Probe Kit
    • Activating non-synonymous mutations in and around the ALK kinase domain by NGS
    • ALK copy number gains by NGS
    • Patients with melanoma and high ALK expression by IHC
  • ECOG PS 0-2
  • No prior treatment with any ALK inhibitor
  • Following tumor types are not eligible
    • Non-small cell lung cancer (NSCLC)
    • Neuroblastoma
    • Childhood tumors
Objective

Primary: ORR

Secondary: DCR, PFS, 1-year OS

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
ALK gene rearrangements (by NGS or FISH), ALK mutations (NGS), ALK copy number gain (NGS)
Dosing Frequency

Alectinib 600 mg PO bid

Control Agents
N/A
Study Protocol
Randomized
No
X