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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463814
First Posted: April 20, 2007
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463814


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00463814     History of Changes
Other Study ID Numbers: D1532C00005
First Submitted: April 18, 2007
First Posted: April 20, 2007
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by AstraZeneca:
Advanced Malignancy
Cancer Eligibility
Malignancy

Additional relevant MeSH terms:
Neoplasms