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OpenTrials
Completed

NCT Number: NCT00731263

A Study of Tor Kinase Inhibitor in Advanced Tumors

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

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Key information

Conditions

Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Clichy, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
  • Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
  • Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

Exclusion criteria

  • Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
  • Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
  • Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
  • Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Treatment and study plan

AZD8055

Drug

Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.

Primary outcomes

  1. Safety and tolerability of AZD8055

    Time frame: Assessed at all visits

Secondary outcomes

  1. To identify early signals of anti-tumour activity

    Time frame: Visits 1, 5, and 9 and 11

  2. To identify early signals of anti-tumor activity

    Time frame: Visits 1, 5, 9 and 13

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2008
Registry last updated
Jul 11, 2012

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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