Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Intervention: AZD2014
Intervention description: Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Phase I; cancer; advanced solid malignancies; dose escalation; AZD2014; mTor kinase inhibitor; safety; pharmacokinetics

Summary:

      The main purpose of the study is to establish a safe dose of the drug by providing
      information on any potential side effects this drug may cause and collecting data about how a
      patient's cancer responds to the drug. The study will also assess the blood levels and action
      of AZD2014 in the body over a period of time and will indicate whether the drug has an effect
      on the types of cancer the patients have.
    

Eligibility criteria:

        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 prior to 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