AZD8330 First Time in Man in Patients With Advanced Malignancies

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00454090
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-29
• Primary Completion: 2010-10
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Cancer which is refractory to standard therapies, or no therapies exist;

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Exclusion Criteria

• Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start;
• Hasn't participated in investigation drug study within 30 days;
• Brain metastases/spinal cord compression unless treated and stable,
• Off steroids/anticonvulsants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation

Secondary Outcome Measures

Name	Time	Method
To determine the PK of AZD8330.
To investigate possible PD/PK relationships
To investigate effect of AZD8330 on pERK in PBMCs

Trial Locations

Locations (1)

Research Site; 🇳🇴 Oslo, Norway