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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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Tumors
Carcinoma
Cancer

Treatments

Drug: AZD4877

Study type

Interventional

Funder types

Industry

Identifiers

NCT00613652
D2782C00008

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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