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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 7, 2009
Last updated: June 14, 2011
Last verified: June 2011

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

Condition Intervention Phase
Solid Tumors
Advanced Solid Malignancies
Drug: AZD8055
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, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) [ Time Frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours [ Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Every cycle ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD8055
AZD8055 will be administered orally
Drug: AZD8055
Tablets, orally administered, twice daily


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT00973076

Research Site
Tokyo, Japan
Sponsors and Collaborators
Study Director: Ian Smith AstraZeneca
Principal Investigator: Tomohide Tamura National Cancer Center Hospital
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca Pharmaceuticals Identifier: NCT00973076     History of Changes
Other Study ID Numbers: D1600C00003
Study First Received: September 7, 2009
Last Updated: June 14, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I, cancer
solid tumors
advanced solid malignancies
dose escalation
mTOR Kinase Inhibitor

Additional relevant MeSH terms:
Neoplasms processed this record on April 15, 2014