A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of a Solid Oral Dosage Formulation (Capsule) of AZD6244 in Patients With Advanced Solid Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Tumor, Cancer
Both
Tumor, Cancer
Trial Information
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of a Solid Oral Dosage Formulation (Capsule) of AZD6244 in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- cancer which is refractory to standard therapies
- WHO performance status 0-2
- evidence of post-menopausal status or negative pregnancy test
Exclusion Criteria:
- Radiotherapy/chemotherapy within 21 days prior to entry
- brain metastases/spinal cord compression unless stable off steroids/anticonvulsants
- evidence of severe/uncontrolled systemic disease
- participated in an investigational drug study within 30 days
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the pharmacokinetics of the solid dose form of AZD6244
Outcome Time Frame:
each visit
Safety Issue:
No
Principal Investigator
Emerging Oncology Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D1532C00005
NCT ID:
NCT00463814
Start Date:
March 2007
Completion Date:
August 2013
Related Keywords:
- Tumor
- Cancer
- Advanced Malignancy
- Cancer Eligibility
- Malignancy
- Neoplasms
Name | Location |
|---|---|
| Research Site | Boulder, Colorado |
