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A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Malignancies

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Trial Information

A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Histological or cytological confirmation of a solid, malignant tumour that is
refractory to standard therapies or for which no standard therapies exist

- At least one lesion (measurable and/or non-measurable) that can be accurately
assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI)
or plain X-ray and is suitable for repeated assessment

- World Health Organisation performance status 0-2 with no deterioration over the
previous 2 weeks and minimum life expectancy of 12 weeks

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, type I or uncontrolled type II diabetes

- 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 AZD2014

Outcome Time Frame:

Assessed at all visits

Safety Issue:

Yes

Principal Investigator

Dr. Udai Banerji

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D2270C00001

NCT ID:

NCT01026402

Start Date:

December 2009

Completion Date:

June 2014

Related Keywords:

  • Advanced Solid Malignancies
  • Phase I
  • cancer
  • advanced solid malignancies
  • dose escalation
  • AZD2014
  • mTor kinase inhibitor
  • safety
  • pharmacokinetics
  • Neoplasms

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