West Cancer Center

LUNG: Metastatic; NSCLC; Phase 1; ALK+; HSP-90 inhibitor; "AT13387-05"

A study of HSP90 inhibitor AT13387 alone and in combination with crizotinib in the treatment of non-small cell lung cancer (NSCLC)

Title

Astex AT13387-05

Study Title

A study of HSP90 inhibitor AT13387 alone and in combination with crizotinib in the treatment of non-small cell lung cancer (NSCLC)

Site Link

NCT01712217

Malignancy

Lung Cancer, NSCLC

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

>_2nd line (must be receiving or have received crizotinib)

Investigational Agent

AT13387

Drug Class

HSP-90 inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Astex Pharmaceuticals

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/study/NCT01712217

Key Eligibility Criteria Details

NSCLC with ALK+ mutation (or similar, such as ROS1)
Must have been receiving or have received crizotinib
Measurable disease
No chemo/XRT within 3 weeks (other than crizotinib)

Objective

PART A: Primary- DLT; Secondary- PK, anti-tumor activity: PART B+C: Primary- ORR; Secondary- Safety, PFS, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ALK mutation or other mutations sensitive to crizotinib (eg. ROS1)

Dosing Frequency

AT13387 IV weekly for 3 weeks in 4 week cycle; crizotinib 250 mg PO bid

Control Agents

Crizotinib alone (Part B); AT13387 alone (Part C)

Study Protocol

Randomized

Yes