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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003158
• Other study ID #: D0102C00010
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2009
• Last updated: July 9, 2014
• Start date: October 2009
• Est. completion date: April 2012

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• AZD8931
Tablet Oral bid
• Paclitaxel
IV once weekly for 3 weeks followed by a week off

Locations

Country	Name	City	State
Japan	Research Site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Clinical Study Protocol Redacted
•   Reducted Protocol