A Study of Tor Kinase Inhibitor in Advanced Tumors

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00731263

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Safety and tolerability of AZD8055 [Assessed at all visits]

Secondary Outcome Measures

To identify early signals of anti-tumour activity [Visits 1, 5, and 9 and 11]
To identify early signals of anti-tumor activity [Visits 1, 5, 9 and 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	New York	New York	United States	10065
2	Research Site	Houston	Texas	United States
3	Research Site	Clichy		France
4	Research Site	Sutton	Surrey	United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

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