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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613652
• Other study ID #: D2782C00008
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2008
• Last updated: July 20, 2009
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Tumors

Intervention

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

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies		weekly	Yes
Secondary	To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies		weekly	No