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
Phase 1
- Conditions
- eoplasms, Metastatic Cancer, Breast Cancer
- Registration Number
- JPRN-jRCT2080220921
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations.<br>Combination part: The contents of same assessment as Monotherlapy.<br>Monotherapy part: Full routine safety assessment on days 1-4,8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug<br>Combination part: Full routine safety assessment on days 1-5, 8, 15, 22, 28 then every 4 weeks after first dose of study drug
- Secondary Outcome Measures
Name Time Method 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)<br>Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10)<br>Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10)<br>Monotherapy Part: On Day 1 (D1) and 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.<br>Combination Part (AZD8931): On Day 7 (D7) and Day 8 (D8): pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose.<br>Combination Part (paclitaxel): On Day 1 (D1) and Day 8 (D8): samples taken pre-infusion then 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 24 (D1 only) hours post start of infusion