Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

Cancer Clinical Trial

Official title:

A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973076
• Other study ID #: D1600C00003
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2009
• Last updated: June 14, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective

• Relatively good overall health other than cancer

Exclusion Criteria:

• Poor bone marrow function (not producing enough blood cells)

• Poor liver or kidney function

• Serious concomitant illness

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Cancer
• Solid Tumors

Intervention

Drug:
• AZD8055
Tablets, orally administered, twice daily

Locations

Country	Name	City	State
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)		Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.	Yes
Secondary	To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours		According to protocol specified schedule, the number of PK samples collected during Cycle 1	No
Secondary	To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)		Every cycle	No