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AZD8330 First Time in Man in Patients With Advanced Malignancies

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 27, 2007
Last updated: August 23, 2011
Last verified: August 2011
The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Condition Intervention Phase
Cancer Drug: AZD8330 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • To determine the PK of AZD8330.
  • To investigate possible PD/PK relationships
  • To investigate effect of AZD8330 on pERK in PBMCs

Enrollment: 83
Study Start Date: March 2007
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD8330
    oral tablet
    Other Name: ARRY-424704

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00454090

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Oslo, Norway
Sponsors and Collaborators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca Identifier: NCT00454090     History of Changes
Other Study ID Numbers: D1536C00001
Study First Received: March 27, 2007
Last Updated: August 23, 2011

Keywords provided by AstraZeneca:
Advanced Malignancies processed this record on September 21, 2017