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AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Patients With Advanced Solid Malignancies

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 18, 2007
Last updated: July 25, 2017
Last verified: July 2017
The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in patients with advanced solid malignancies.

Condition Intervention Phase
Tumor Cancer Drug: AZD6244 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the pharmacokinetics of the solid dose form of AZD6244 [ Time Frame: each visit ]

Secondary Outcome Measures:
  • To assess safety and tolerability of solid dose form of AZD6244 [ Time Frame: assessed at each visit ]

Enrollment: 58
Actual Study Start Date: March 8, 2007
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: June 17, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD6244 Drug: AZD6244
oral capsule
Other Name: ARRY-142886


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00463814

United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
Research Site
Nijmegen, Netherlands, 6525 GA
Research Site
Utrecht, Netherlands, 3584 CX
United Kingdom
Research Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00463814     History of Changes
Other Study ID Numbers: D1532C00005
Study First Received: April 18, 2007
Last Updated: July 25, 2017

Keywords provided by AstraZeneca:
Advanced Malignancy
Cancer Eligibility

Additional relevant MeSH terms:
Neoplasms processed this record on September 21, 2017