A Study of Tor Kinase Inhibitor in Advanced Tumors - Full Text View

Purpose

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	Intervention	Phase
Solid Tumors	Drug: AZD8055	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability of AZD8055 [ Time Frame: Assessed at all visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To identify early signals of anti-tumour activity [ Time Frame: Visits 1, 5, and 9 and 11 ] [ Designated as safety issue: No ]
To identify early signals of anti-tumor activity [ Time Frame: Visits 1, 5, 9 and 13 ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	July 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731263

Locations

United States, New York
Research Site
New York, New York, United States, 10065
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Clichy, France
United Kingdom
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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00731263 History of Changes
Other Study ID Numbers:	D1600C00001, 2008-002606-19
Study First Received:	August 6, 2008
Last Updated:	July 10, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:

Cancer
Advance solid tumours
Dose Escalation
Preliminary efficacy

AZD8055
Tor kinase inhibitor
Oral administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013