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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00463814
First received: April 18, 2007
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 90
Study Start Date: March 2007
Estimated Study Completion Date: August 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD6244 Drug: AZD6244
oral capsule
Other Name: ARRY-142886

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463814

Locations
United States, Colorado
Research Site
Aurora, Colorado, United States
Research site
Denver, Colorado, United States
Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Utrecht, Netherlands
United Kingdom
Research Site
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: April 18, 2007
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced Malignancy
Cancer Eligibility
Malignancy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013