A Study of Tor Kinase Inhibitor in Advanced Tumors

Solid Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731263
• Other study ID #: D1600C00001
• Secondary ID: 2008-002606-19
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2008
• Last updated: July 10, 2012
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.

Locations

Country	Name	City	State
France	Research Site	Clichy
United Kingdom	Research Site	Sutton	Surrey
United States	Research Site	Houston	Texas
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of AZD8055		Assessed at all visits	Yes
Secondary	To identify early signals of anti-tumour activity		Visits 1, 5, and 9 and 11	No
Secondary	To identify early signals of anti-tumor activity		Visits 1, 5, 9 and 13	No

External Links

•   Cancer Study Locator (US and Canada only)