Study Stopped
Decision to stop development of AZD1480
Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours
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.
1 other identifier
interventional
72
1 country
3
Brief Summary
This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2010
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 22, 2013
July 1, 2013
2.4 years
April 23, 2010
July 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluation of the pharmacokinetics of AZD1480
During all cycles
Study Arms (2)
1
EXPERIMENTALAZD1480 until Maximum Tolerated Dose (MTD) is reached
2
EXPERIMENTALAZD1480 dose expansion of MTD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Aurora, Colorado, United States
Research Site
Detroit, Michigan, United States
Research Site
Philadelphia, Pennsylvania, United States
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY CHAIR
Gregory Curt, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 28, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 22, 2013
Record last verified: 2013-07