Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours
- Registration Number
- NCT01112397
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD1480 AZD1480 until Maximum Tolerated Dose (MTD) is reached 2 AZD1480 AZD1480 dose expansion of MTD
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Evaluation of the pharmacokinetics of AZD1480 During all cycles
Trial Locations
- Locations (1)
Research Site
🇺🇸Philadelphia, Pennsylvania, United States