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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00973076
First received: September 7, 2009
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Cancer
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973076

Locations
Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov 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
Japanese

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014