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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00463814
Collaborator
(none)
58
Enrollment
4
Locations
1
Arm
189.8
Anticipated Duration (Months)
14.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
N/A
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 :
Mar 8, 2007
Actual Primary Completion Date :
Jun 17, 2008
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD6244

Drug: AZD6244
oral capsule
Other Names:
  • ARRY-142886

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the pharmacokinetics of the solid dose form of AZD6244 [each visit]

    Secondary Outcome Measures

    1. To assess safety and tolerability of solid dose form of AZD6244 [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Aurora Colorado United States 80045
    2 Research Site Nijmegen Netherlands 6525 GA
    3 Research Site Utrecht Netherlands 3584 CX
    4 Research Site Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Emerging Oncology Medical Science Director, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00463814
    Other Study ID Numbers:
    • D1532C00005
    First Posted:
    Apr 20, 2007
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by AstraZeneca
    Advanced Malignancy
    Cancer Eligibility
    Malignancy
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 27, 2022