Clinical trial NCT00731263: A Study of Tor Kinase Inhibitor in Advanced Tumors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Cancer
Advance solid tumours
Dose Escalation
Preliminary efficacy
AZD8055
Tor kinase inhibitor
Oral administration
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety and tolerability of AZD8055
timeFrame: Assessed at all visits
Secondary outcomes:
measure: To identify early signals of anti-tumour activity
timeFrame: Visits 1, 5, and 9 and 11
measure: To identify early signals of anti-tumor activity
timeFrame: Visits 1, 5, 9 and 13
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Houston
country: United States
facility: Research Site
state: Texas
city: Clichy
country: France
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
state: Surrey
Study officials:
affiliation: Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT
name: Prof Stan Kaye
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA
name: Dr Carol Aghajanian
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA
name: Dr Aung Naing
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France
name: Professor Eric Raymond
role: PRINCIPAL_INVESTIGATOR
References: