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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Neoplasms, Metastatic Cancer, Breast Cancer

Thank you

Trial Information

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


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:

- Inadequate kidney, liver, heart, gastric, lung or eye function

- Brain metastases

- Hypersensitive to paclitaxel (combination part)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations.

Outcome Time Frame:

Full routine safety assessment on days 1-4, 8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug

Safety Issue:

No

Principal Investigator

Mary Stuart, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D0102C00010

NCT ID:

NCT01003158

Start Date:

October 2009

Completion Date:

April 2012

Related Keywords:

  • Neoplasms
  • Metastatic Cancer
  • Breast Cancer
  • Cancer
  • tumour
  • metastatic
  • breast cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location