West Cancer Center

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

Site Link

NCT02091141

Malignancy

Ovarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line or greater

Investigational Agent

Alectinib

Drug Class

ALK inhibitor

Ari VanderWalde

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02091141

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

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