Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01003158

Enrollment

Registered

2009-10-28

Start date

2009-10-31

Completion date

2012-04-30

Last updated

2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Metastatic Cancer, Breast Cancer

Keywords

Cancer, tumour, metastatic, breast cancer

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.

Interventions

DRUGAZD8931

Tablet Oral bid

DRUGPaclitaxel

IV once weekly for 3 weeks followed by a week off

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026