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

This study is ongoing, but not recruiting participants.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00463814

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 I

MedlinePlus related topics: Cancer

Drug Information available for: ARRY 142886

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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 ] [ 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:	April 2009

Intervention Details:

oral capsule

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
Denver, Colorado, United States
Research Site
Aurora, Colorado, United States
Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Utrecht, Netherlands
United Kingdom, Surrey
Research Site
Sutton, Surrey, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Emerging Oncology Medical Science Director, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D1532C00005
Study First Received:	April 18, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00463814
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 January 16, 2009