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A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

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ClinicalTrials.gov Identifier: NCT00613652
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies

Condition or disease Intervention/treatment Phase
Cancer Tumors Carcinoma Drug: AZD4877 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies
Study Start Date : January 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009
Arms and Interventions

Intervention Details:
    Drug: AZD4877
    10 mg IV (3 weeks treatment 1 week rest)

Outcome Measures

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies [ Time Frame: weekly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
  • Patients who usually have mild symptoms capable of walking and light and sedentary work.
  • Patients who can stay in hospital at least during 4 weeks.

Exclusion Criteria:

  • Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
  • Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
  • Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
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): NCT00613652


Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00613652     History of Changes
Other Study ID Numbers: D2782C00008
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by AstraZeneca:
solid tumors
solid malignancies