AZD8330 First Time in Man in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00454090
First received: March 27, 2007
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: March 27, 2007
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced Malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014