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A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 Using Intermittent Dosing Schedules in Patients With Advanced Solid Malignancies and Lymphomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Advanced Solid Tumours, Lymphomas

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Trial Information

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 Using Intermittent Dosing Schedules in Patients With Advanced Solid Malignancies and Lymphomas


Inclusion Criteria:



- Histological or cytological confirmation of an advanced solid malignant tumour or
lymphoma which is refactory to standard therapies or for which no standard therapy
exists, patients with measurable or non-measurable disease (according to RECIST
criteria)

- WHO performance status 0-2

- 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.

- Any investigational agents or study drugs from a previous clinical study within 30
days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of
the first dose of study treatment

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.

Outcome Time Frame:

Evaluability period is 5 weeks (visit 5), although safety and tolerability parameters will be measured at all visits.

Safety Issue:

Yes

Principal Investigator

Ian Smith, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca R&D

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D1600C00002

NCT ID:

NCT01194193

Start Date:

Completion Date:

Related Keywords:

  • Cancer
  • Advanced Solid Tumours
  • Lymphomas
  • Cancer
  • Advanced solid tumours
  • lymphomas
  • dose escalation
  • preliminary anti-tumour activity
  • Tor kinase inhibitor
  • oral administration
  • intermittent dosing
  • Lymphoma

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