Trial ID or NCT#

NCT01625234

Status

RECRUITING

Purpose

This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.

Official Title

Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 (Ensartinib) in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Heather Wakelee, MD
Medical oncologist, Thoracic specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Assistant Professor of Medicine (Oncology) at the Stanford University Medical Center
Kavitha Ramchandran
Medical oncologist, Palliative medicine doctor, Thoracic specialist, Internal medicine doctor
Clinical Assistant Professor, Medicine - Oncology
Millie Das, MD
Medical oncologist, Thoracic specialist
Clinical Assistant Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

CONTACT

Melanie San Pedro-Salcedo
(650) 724-1388