A Phase I, Open-label, Multiple-dose, Dose-escalation Study To Assess the Safety and Tolerability of AZD8931 Monotherapy in Japanese Patients With Advanced Solid Malignancies and in Combination With Paclitaxel in Japanese Female Patients With Advanced Breast Cancer
Sponsor study identifier
interventional
17
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 20, 2009
Actual (reported)October 28, 2009
Actual (reported)April 2012
Actual (reported)April 2012
Actual (reported)Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations.
Full routine safety assessment on days 1-4, 8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug
Combination part: The contents of same assessment as Monotherapy.
Full routine safety assessment on days 1-5, 8, 15, 22, 28 then every 4 weeks after first dose of study drug
Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10)
On Day D7 and Day D8: pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose
Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10)
On Days D1 and Day D8: pre-infusion then, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 24 (D1 only) hours post start of infusion
Monotherapy Part: Pharmacokinetics of AZD8931 (Single dose plasma PK: AUC0-10, AUC0-12, AUC0-24, AUC0-t, AUC, Cmax, tmax, t1/2, CL/F, Vss/F. Multiple dose plasma PK: AUCss0-10, AUCss0-12, Cssmax, tssmax, Cssmin, CLss/F, RAC, linearity factor)
On single dose Day 1 (D1) and multiple dose Day 21 (R14): samples taken pre-dose then 1, 2, 4, 6, 8, 10, 24 (D1 only), 48 (D1 only) and 72 (D1 only) hours post dose. Day 10 (R3) and Day 14 (R7): pre-dose only
AZD8931 monotherapy
AZD8931 plus paclitaxel
Tablet Oral bid
IV once weekly for 3 weeks followed by a week off
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Osaka, Japan
Kurata T, Tsurutani J, Fujisaka Y, Okamoto W, Hayashi H, Kawakami H, Shin E, Hayashi N, Nakagawa K. Inhibition of EGFR, HER2 and HER3 signaling with AZD8931 alone and in combination with paclitaxel: phase i study in Japanese patients with advanced solid malignancies and advanced breast cancer. Invest New Drugs. 2014 Oct;32(5):946-54. doi: 10.1007/s10637-014-0112-7. Epub 2014 May 31.
Mary Stuart, Dr.
AstraZeneca
Takayasu Kurata, Dr.
Kinki University School of Medicine
17 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2009
First Posted
October 28, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
July 10, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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