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A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Malignancies

Thank you

Trial Information

A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.


Inclusion Criteria:



- Patients with advanced solid cancer without available therapy in the escalation
phase and mutation positive NSCLC or non-smokers with other primary tumors lung
metastasis in the expansion phase

- ECOG Performance Status 0-1

- Evidence of post-menopausal status in females or males willing to use barrier
contraception

Exclusion Criteria:

- Prior therapy with any JAK2 medications

- Significant lung disorder or lung disease. Previous radiation therapy to chest wall
or chest infection requiring antibiotic treatment within 21 days before study
screening. Evidence of significant pulmonary hypertension or COPD

- Eye disease of the cornea

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis)

Outcome Time Frame:

Information will be collected from the time the informed consent is signed, throughout the study

Safety Issue:

Yes

Principal Investigator

Gregory Curt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1060C00002

NCT ID:

NCT01112397

Start Date:

April 2010

Completion Date:

August 2013

Related Keywords:

  • Solid Malignancies
  • Jak2
  • cancer
  • jak 1
  • stat 3
  • Phase 1
  • Neoplasms

Name

Location

Research SiteBoulder, Colorado  
Research SiteBattle Kreek, Michigan  
Research SiteAllentown, Pennsylvania