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

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ClinicalTrials.gov Identifier: NCT00463814
Recruitment Status : Active, not recruiting
First Posted : April 20, 2007
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Tumor Cancer Drug: AZD6244 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Actual Study Start Date : March 8, 2007
Primary Completion Date : June 17, 2008
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: AZD6244 Drug: AZD6244
oral capsule
Other Name: ARRY-142886



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

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


Information from the National Library of Medicine

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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

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

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 Posted: April 20, 2007    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by AstraZeneca:
Advanced Malignancy
Cancer Eligibility
Malignancy

Additional relevant MeSH terms:
Neoplasms