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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00973076
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer; Solid Tumors; Advanced Solid Malignancies	Drug: AZD8055	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD8055 AZD8055 will be administered orally	Drug: AZD8055; Tablets, orally administered, twice daily

Outcome Measures

Primary Outcome Measures

1. 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.]

Secondary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Tokyo		Japan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Ian Smith, AstraZeneca
• Principal Investigator: Tomohide Tamura, National Cancer Center Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00973076
• Other Study ID Numbers: D1600C00003
• First Posted: Sep 9, 2009
• Last Update Posted: Jun 15, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Phase I, cancer; solid tumors; advanced solid malignancies; dose escalation; mTOR Kinase Inhibitor; Japanese
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jun 15, 2011