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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

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
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220921
Enrollment
Unknown
Registered
2009-11-19
Start date
2009-11-19
Completion date
Unknown
Last updated
2026-06-29

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

Interventions

investigational material(s) Generic name etc : AZD8931 for Monotherapy part INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inv

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: -Inadequate kidney, liver, heart, gastric, lung or eye function -Brain metastases -Hypersensitive to paclitaxel (combination part)

Design outcomes

Primary

MeasureTime frame
Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations. Combination part: The contents of same assessment as Monotherlapy. 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 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

MeasureTime frame
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) Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10) Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10) 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. Combination Part (AZD8931): On Day 7 (D7) and Day 8 (D8): pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose. 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—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026