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Completed

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

ClinicalTrials.gov ID NCT01353781
Sponsor AstraZeneca
Information provided by AstraZeneca (Responsible Party)
Last Update Posted 2016-04-26
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Study Overview

Brief Summary
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.
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
Conditions
Advanced Solid Malignancy
Advanced Solid Tumor
Intervention / Treatment
  • Drug: AZD5363
  • Drug: AZD5363
Other Study ID Numbers
  • D3610C00004
Study Start
2011-06
Primary Completion (Actual)
2014-07
Study Completion (Actual)
2014-07
Enrollment (Estimated)
39
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
Japan
Chuo-ku, Japan

Research Site
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
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Ages Eligible for Study
20 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Non-Randomized
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: AZD5363
Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD)
Intervention/Treatment 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.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orallyTo 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 malignanciesAll 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
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.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 MTDonce 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)
To characterise the pharmacokinetics parameters CminTo characterise the pharmacokinetics parameters Cmin of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
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

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.

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 characterise the pharmacokinetics parameters(Cmax)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 malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters tmaxTo characterise the pharmacokinetics parameters tmax of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters AUCTo 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 malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters CL/FTo 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 malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters Vz/FTo 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 malignanciesPK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
AstraZeneca
Investigators
  • Study Director:Paul Stockman, MD,AstraZeneca

Publications

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2011-04-11
First Submitted that Met QC Criteria
2011-05-13
First Posted (Estimated)
2011-05-16
Study Record Updates
Last Update Submitted that met QC Criteria
2016-04-25
Last Update Posted (Estimated)
2016-04-26
Last Verified
2016-04

More Information

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Keywords Provided by AstraZeneca
Additional Relevant MeSH Terms