West Cancer Center

MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors

Title

Genentech ML42439 (myTACTIC) ALK

Study Title

Site Link

NCT04632992

Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
Not Non-small cell lung cancer (NO NSCLC)
ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib

Objective

Primary-
- ORR
Secondary
- PFS
- oR
- OS
- PFS at various time poitns
- DCR
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Dosing Frequency

Control Agents

Study Protocol

Randomized