West Cancer Center

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; ALK/ROS1+; "SIGNATURE CLDK378AUS23"

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module-7; ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1

Title

Novartis CLDK378AUS23

Study Title

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module-7; ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1

Site Link

NCT02186821

Malignancy

y- breast, colon, prostate, colorectal, sarcoma, melanoma, bladder, renal, head and neck, leukemia, lymphoma, gastric, esophageal, ROS1 positive lung

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>/= 2nd line

Investigational Agent

Ceritinib

Drug Class

ALK inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02186821

Key Eligibility Criteria Details

ALK or ROS1 mutation, trnaslocation, rearrangement, or amplification by CLIA-certified laboratory (IHC or FISH allowed)

May not have ALK+ lung cancer (butROS1 positive lung CA allowed)
Relapsed or progressive disease
ECOG PS 0-1
2nd line or higher
No standard therapy withdurable remission expected
No CNS disease

Objective

Primary- Clinical Benefit Rate: Secondary- ORR, PFS, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ALK or ROS1 mutation, translocation, rearrangement, or amplification

Dosing Frequency

Ceritinib 750mg PO qday

Control Agents

N/A

Study Protocol

Randomized