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A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00613652
Enrollment
30
Registered
2008-02-13
Start date
2008-01-31
Completion date
2009-06-30
Last updated
2009-07-21

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

Conditions

Cancer, Carcinoma, Tumors

Keywords

solid tumors, solid malignancies

Brief summary

The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies

Interventions

10 mg IV (3 weeks treatment 1 week rest)

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments. * Patients who usually have mild symptoms capable of walking and light and sedentary work. * Patients who can stay in hospital at least during 4 weeks.

Exclusion criteria

* Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin. * Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function. * Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignanciesweekly

Secondary

MeasureTime frame
To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignanciesweekly

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026