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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01226316
Other study ID # D3610C00001
Secondary ID EudraCT number:
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2010
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.


Description:

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 Patients with Advanced Solid Malignancies.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 285
Est. completion date December 31, 2024
Est. primary completion date April 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: - Aged at least 18 years. - Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist. - ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F). - The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks. - Estimated life expectancy of more than 12 weeks. Exclusion Criteria: - Clinically significant abnormalities of glucose metabolism. - Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids). - Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. - Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures. - A bad reaction to AZD5363 or any drugs similar to it in structure or class.

Study Design


Intervention

Drug:
AZD5363
Patients will receive a single dose of AZD5363, administered orally, followed by a 3-7 day wash-out period. Patients will then commence with twice-daily dosing, administered orally, every day, to cessation of therapy.
AZD5363
Patients will be given AZD5363 administered orally as a single dose, followed by a 3-7 day wash-out period. Patients will then receive AZD5363 twice daily on 6 or fewer days per weekly regimen, to cessation of therapy. Parts C,D: Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment, to cessation of therapy.
AZD5363
Optional additional schedule. Patients will be given AZD5363 administered orally. Regimen to be determined in response to emerging clinical findings.
AZD5363
Patients will receive oral AZD5363 twice daily (4 days on 3 days off treatment)combined with background therapy of fulvestrant at licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter.

Locations

Country Name City State
Canada Research Site Edmonton Alberta
Canada Research Site Montreal Quebec
Canada Research Site Toronto Ontario
Canada Research Site Vancouver British Columbia
Denmark Research Site København Ø
France Research Site Paris Cedex 5
France Research Site Pierre Benite CEDEX
France Research Site Villejuif
Italy Research Site Milan
Italy Research Site Napoli
Italy Research Site Prato
Japan Research Site Chuo-ku
Japan Research Site Kashiwa
Japan Research Site Koto-ku
Japan Research Site Sapporo-shi
Netherlands Research Site Amsterdam
Singapore Research Site Singapore
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Valencia
United Kingdom Research Site Manchester
United Kingdom Research Site Sutton
United States Research Site Aurora Colorado
United States Research Site Boston Massachusetts
United States Research Site Charleston South Carolina
United States Research Site Houston Texas
United States Research Site Los Angeles California
United States Research Site Nashville Tennessee
United States Research Site Nashville Tennessee
United States Research Site New York New York
United States Research Site Oklahoma City Oklahoma
United States Research Site Portland Oregon
United States Research Site Stanford California
United States Research Site West Hollywood California

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Italy,  Japan,  Netherlands,  Singapore,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events Adverse events, serious adverse events and deaths will be collected from screening to 28 days after study drug discontinuation.
Primary Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of death Deaths will be collected from screening to 28 days after study drug discontinuation
Primary Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline of laboratory data (clinical chemistry, haematology, urinalysis) Laboratory data will be collected from screening to 28 days after study drug discontinuation
Primary Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 in terms of changes from baseline in vital signs and in electrocardiogram (ECG) parameters Vital signs and ECGs will be recorded from screening to 28 days after study drug discontinuation
Primary Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline in electrocardiogram (ECG) parameters ECGs will be collected from screening to 28 days after study drug discontinuation.
Primary Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline of glucose laboratory parameters (Urine, serum and plasma glucose, glycosylated haemoglobin). Glucose parameters will be collected from screening to 28 days after study discontinuation.
Primary Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing left ventricular ejection fraction (LVEF). Multiple Gated Acquisition (MUGA) or Echocardiogram assessments to be carried out from screening until study drug discontinuation
Secondary To characterise AZD5363 PK following single & multiple dosing by assessment of maximum plasma concentration,time to Cmax, terminal rate constant, terminal half life,area under the plasma concentration-time curve,plasma clearance & volume of distribution. Sample:Part A&B:Cycle0Day1(predose,30min,1,2,4,6,8,10-12,24&48h postdose),C1D1(predose),D8/Last wkly dose(predose,30min,1,2,4,6,8,10-12h postdose),D15/Last wkly dose+7(predose),Part C,D,E&F:C1D1(predose,2,4h postdose)&D11(predose,2,4h postdose)
Secondary Parts A,B,C,D,E&F: To obtain a preliminary assessment of anti-tumour activity of AZD5363 via use of Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Tumour assessment by RECIST at 6,12,18,24wks then at 12 weekly intervals until discontinuation of study therapy
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