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A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Advanced Solid Malignancy, Advanced Solid Tumor

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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 Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Aged at least 20 years

- Histological or cytological confirmation of a solid malignant tumour, excluding
lymphoma, 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 according to RECIST

- World Health Organisation (WHO) performance status 0-1 with no deterioration over the
previous 2 weeks and minimum life expectancy of 12 weeks

- Patients should be willing to remain in hospital until the completion of the first
cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)

Exclusion Criteria:

- Clinically significant abnormalities of glucose metabolism as defined by any of the
following:

- Diagnosis of diabetes mellitus type I or II (irrespective of management)

- Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)

- Glycosylated haemoglobin (HbA1C) >6.5%

- Spinal cord compression or brain metastases unless asymptomatic, treated and stable
and not requiring steroids for at least 4 weeks prior to start of study treatment

- Inadequate bone marrow reserve or organ function

- Any evidence of severe or uncontrolled systemic diseases, including active bleeding
diatheses, or active infection

- With the exception of alopecia, any unresolved toxicities from prior therapy greater
than CTCAE grade 1 at the time of starting study treatment

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:

To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally

Outcome Description:

To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies

Outcome Time Frame:

All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive

Safety Issue:

Yes

Principal Investigator

Paul Stockman, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D3610C00004

NCT ID:

NCT01353781

Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Advanced Solid Malignancy
  • Advanced Solid Tumor
  • Phase 1
  • advanced solid tumor
  • AKT
  • Ascending
  • Japanese
  • Neoplasms

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