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

NCT ID: NCT01112397

Last Updated: 2013-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Conditions

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Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD1480 until Maximum Tolerated Dose (MTD) is reached

Group Type EXPERIMENTAL

AZD1480

Intervention Type DRUG

continuous daily oral capsule

2

AZD1480 dose expansion of MTD

Group Type EXPERIMENTAL

AZD1480

Intervention Type DRUG

continuous daily oral capsule

Interventions

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AZD1480

continuous daily oral capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Curt, MD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Aurora, Colorado, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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D1060C00002

Identifier Type: -

Identifier Source: org_study_id

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