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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00613652
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 1.8

Study Details

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
• Anticipated 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: Jan 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

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 [weekly]

Secondary Outcome Measures

1. To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies [weekly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Fukuoka		Japan

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00613652
• Other Study ID Numbers: D2782C00008
• First Posted: Feb 13, 2008
• Last Update Posted: Jul 21, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: solid tumors; solid malignancies

Study Results

No Results Posted as of Jul 21, 2009