Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

Solid Malignancies Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01112397
• Other study ID #: D1060C00002
• Status: Terminated
• Phase: Phase 1
• First received: April 23, 2010
• Last updated: July 19, 2013
• Start date: April 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Malignancies

Intervention

Drug:
• AZD1480
continuous daily oral capsule

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Detroit	Michigan
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Information will be collected from the time the informed consent is signed, throughout the study	Yes
Secondary	Evaluation of the pharmacokinetics of AZD1480		During all cycles	No

External Links

•   Cancer Study Locator (US and Canada only)