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Completed

NCT Number: NCT00973076

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

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

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Key information

Conditions

Cancer Advanced Solid Malignancies Neoplasms Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8055

Drug

Tablets, orally administered, twice daily

Primary outcomes

  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)

    Time frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.

Secondary outcomes

  1. 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

  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)

    Time frame: Every cycle

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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