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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
Open (Enrolling)
Both
Tumor, Cancer

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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 SiteBoulder, Colorado