A Study of Tor Kinase Inhibitor in Advanced Tumors

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.

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: AZD8055

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of AZD8055	Assessed at all visits

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 6, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Cancer; Dose Escalation; Advance solid tumours; Preliminary efficacy; AZD8055; Tor kinase inhibitor; Oral administration
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: D1600C00001; 2008-002606-19