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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


Phase 1
20 Years
75 Years
Not Enrolling
Both
Cancer, Tumors, Carcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

weekly

Safety Issue:

Yes

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D2782C00008

NCT ID:

NCT00613652

Start Date:

January 2008

Completion Date:

June 2009

Related Keywords:

  • Cancer
  • Tumors
  • Carcinoma
  • solid tumors
  • solid malignancies
  • Carcinoma

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