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.
Verified date | July 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Aurora | Colorado |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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