FindTrial
Sign In

A Phase I, Open-Label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

A Phase I, Open-Label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220492
Enrollment
Unknown
Registered
2007-12-25
Start date
2007-12-25
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

Advanced Solid Malignancies

Interventions

investigational material(s) Generic name etc : AZD2281(KU-0059436) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 20 Years to 74 Years Genders Eligible for Study: Both Inclusion Criteria: - Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: - Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety/Efficacy Primary Outcome Measures:The primary objective of this study is to determine the safety and tolerability of AZD2281. [Time Frame: assessed after each visit] [Designated as safety issue: No] Secondary Outcome Measures:The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. [Time Frame: assessed after each visit] [Designated as safety issue: No]—

Outcome results

None listed

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