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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01353781
First received: April 11, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Advanced Solid Malignancy
Advanced Solid Tumor
Drug: AZD5363
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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

  • To characterise the pharmacokinetics parameters Cmin [ Time Frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]

    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.


  • To characterise the pharmacokinetics parameters(Cmax) [ Time Frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15. ] [ Designated as safety issue: No ]
    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

  • To characterise the pharmacokinetics parameters tmax [ Time Frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15. ] [ Designated as safety issue: No ]
    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

  • To characterise the pharmacokinetics parameters AUC [ Time Frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 39
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD5363
Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD)
Drug: AZD5363
Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353781

Contacts
Contact: AstraZeneca Clinical Study Information 001-800-236-9933 information.center@astrazeneca.com

Locations
Japan
Research Site Recruiting
Nagoya, Aichi, Japan
Research site Recruiting
Sapporo, Hokkaido, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul Stockman, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01353781     History of Changes
Other Study ID Numbers: D3610C00004
Study First Received: April 11, 2011
Last Updated: February 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase 1
advanced solid tumor
AKT
Ascending
Japanese

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014