A Study of Tor Kinase Inhibitor in Advanced Tumors

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: AZD8055


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advance solid tumours, Dose Escalation, Preliminary efficacy, AZD8055, Tor kinase inhibitor, Oral administration