NCT01003158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

2.5 years

First QC Date

October 20, 2009

Last Update Submit

July 9, 2014

Conditions

NeoplasmsMetastatic CancerBreast Cancer

Keywords

Cancertumourmetastaticbreast cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (2)

Monotherapy part

EXPERIMENTAL

AZD8931 monotherapy

Drug: AZD8931

Combination part

EXPERIMENTAL

AZD8931 plus paclitaxel

Drug: AZD8931Drug: Paclitaxel

Interventions

AZD8931DRUG

Tablet Oral bid

Combination partMonotherapy part
PaclitaxelDRUG

IV once weekly for 3 weeks followed by a week off

Combination part

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part)
  • Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part)
  • Life expectancy more than 12 weeks

You may not qualify if:

  • Inadequate kidney, liver, heart, gastric, lung or eye function
  • Brain metastases
  • Hypersensitive to paclitaxel (combination part)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Osaka, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24875132DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisBreast Neoplasms

Interventions

AZD 8931Paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Mary Stuart, Dr.

    AstraZeneca

    STUDY DIRECTOR

  • Takayasu Kurata, Dr.

    Kinki University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

JP(1)