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A Study of Tor Kinase Inhibitor in Advanced Tumors

NCT ID: NCT00731263

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Keywords

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Cancer Advance solid tumours Dose Escalation Preliminary efficacy AZD8055 Tor kinase inhibitor Oral administration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AZD8055

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof Stan Kaye

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT

Dr Carol Aghajanian

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA

Dr Aung Naing

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA

Professor Eric Raymond

Role: PRINCIPAL_INVESTIGATOR

Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France

Locations

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Research Site

New York, New York, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Clichy, , France

Site Status

Research Site

Sutton, Surrey, United Kingdom

Site Status

Countries

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United States France United Kingdom

Other Identifiers

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2008-002606-19

Identifier Type: -

Identifier Source: secondary_id

D1600C00001

Identifier Type: -

Identifier Source: org_study_id