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Completed

NCT Number: NCT01353781

Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

The purpose of this study is 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.

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Key information

Conditions

Advanced Solid Malignancy Advanced Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chūōku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD5363

Drug

Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.

Primary outcomes

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

    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

    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

Secondary outcomes

  1. To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.

    Time frame: once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)

    To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies. A dose will be considered non-tolerated and dose escalation will cease if 2 or more of up to 6 evaluable patients experience a DLT at a dose level. Six evaluable patients are required to determine the MTD

  2. To characterise the pharmacokinetics parameters Cmin

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters Cmin of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

  3. To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies

    Time frame: Assessed every 3 weeks for initial 2 cycles and every 6 weeks for later cycles for all subjects after start of study treatment until discontinuation of study treatment or withdrawal of consent.

    To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  4. To characterise the pharmacokinetics parameters(Cmax)

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters Cmax of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

  5. To characterise the pharmacokinetics parameters tmax

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters tmax of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

  6. To characterise the pharmacokinetics parameters AUC

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters AUC factor of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

  7. To characterise the pharmacokinetics parameters CL/F

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters CL/F factor of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

  8. To characterise the pharmacokinetics parameters Vz/F

    Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

    To characterise the pharmacokinetics parameters Vz/F of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 16, 2011
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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