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.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01112397

Enrollment

Registered

2010-04-28

Start date

2010-04-30

Completion date

2012-09-30

Last updated

2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Malignancies

Keywords

Jak2, cancer, jak 1, stat 3, Phase 1

Brief summary

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

Interventions

DRUGAZD1480

continuous daily oral capsule

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluation of the pharmacokinetics of AZD1480	During all cycles

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026