A Study of Tor Kinase Inhibitor in Advanced Tumors

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: AZD8055

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731263

2008-002606-19

D1600C00001

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

64 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: AZD8055