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NCT00454090 Clinical Trial

AZD8330 First Time in Man in Patients With Advanced Malignancies

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00454090
Other study ID # D1536C00001
Secondary ID
Status Completed
Phase Phase 1
First received March 27, 2007
Last updated August 23, 2011
Start date March 2007
Est. completion date March 2011

Study information
Verified date August 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date March 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD8330
oral tablet

Locations
Country Name City State
Norway Research Site Oslo
United States Research Site Houston Texas
United States Research Site Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Primary Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation
Secondary To determine the PK of AZD8330.
Secondary To investigate possible PD/PK relationships
Secondary To investigate effect of AZD8330 on pERK in PBMCs
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