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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00613652
First received: January 31, 2008
Last updated: July 20, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Cancer
Tumors
Carcinoma
Drug: AZD4877
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD4877
    10 mg IV (3 weeks treatment 1 week rest)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613652

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

No publications provided

ClinicalTrials.gov Identifier: NCT00613652     History of Changes
Other Study ID Numbers: D2782C00008
Study First Received: January 31, 2008
Last Updated: July 20, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
solid tumors
solid malignancies

ClinicalTrials.gov processed this record on September 18, 2014