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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Solid Malignancies

Treatments: Drug: AZD1480

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112397

D1060C00002

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1

Experimental group

Description:

AZD1480 until Maximum Tolerated Dose (MTD) is reached

Treatment:

Drug: AZD1480

2

Experimental group

Description:

AZD1480 dose expansion of MTD

Treatment:

Drug: AZD1480