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AZD8330 First Time in Man in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT00454090
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : August 24, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Cancer Drug: AZD8330 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
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
Study Start Date : March 2007
Primary Completion Date : October 2010
Study Completion Date : March 2011
Arms and Interventions

Intervention Details:
    Drug: AZD8330
    oral tablet
    Other Name: ARRY-424704

Outcome Measures

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

Secondary Outcome Measures :
  1. To determine the PK of AZD8330.
  2. To investigate possible PD/PK relationships
  3. To investigate effect of AZD8330 on pERK in PBMCs

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454090


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00454090     History of Changes
Other Study ID Numbers: D1536C00001
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by AstraZeneca:
Advanced Malignancies

Additional relevant MeSH terms:
Neoplasms