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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Principal Investigator
Emerging Oncology Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D1536C00001
NCT ID:
NCT00454090
Start Date:
March 2007
Completion Date:
March 2011
Related Keywords:
- Cancer
- Advanced Malignancies
- Neoplasms
Name | Location |
|---|---|
| Research Site | Allentown, Pennsylvania |
| Research Site | Abilene, Texas |
