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A Study of Tor Kinase Inhibitor in Advanced Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00731263
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: AZD8055 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1
The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. 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.
Drug: AZD8055
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 Outcome Measures :
  1. Safety and tolerability of AZD8055 [ Time Frame: Assessed at all visits ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00731263

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United States, New York
Research Site
New York, New York, United States, 10065
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Clichy, France
United Kingdom
Research Site
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Prof Stan Kaye Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT
Principal Investigator: Dr Carol Aghajanian Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA
Principal Investigator: Dr Aung Naing MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA
Principal Investigator: Professor Eric Raymond Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France

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Responsible Party: AstraZeneca Identifier: NCT00731263    
Other Study ID Numbers: D1600C00001
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by AstraZeneca:
Advance solid tumours
Dose Escalation
Preliminary efficacy
Tor kinase inhibitor
Oral administration
Additional relevant MeSH terms:
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