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A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies


Phase 1
20 Years
N/A
Not Enrolling
Both
Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer

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Trial Information

A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Japanese patients with non small cell lung cancer or epithelial ovarian cancer

- Must be suitable for treatment with carboplatin and paclitaxel

- Relatively good overall health other than cancer

Exclusion Criteria:

- Poor bone marrow function (not producing enough blood cells).

- Poor liver or kidney function.

- Patients unable to discontinue drugs known to be potent inhibitors or inducers of
CYP3A4 within 2 weeks prior to registration

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:

Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG

Outcome Time Frame:

Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.

Safety Issue:

Yes

Principal Investigator

Mary Stuart

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D8180C00020

NCT ID:

NCT01000896

Start Date:

January 2010

Completion Date:

March 2011

Related Keywords:

  • Cancer
  • Non Small Cell Lung Cancer
  • Epithelial Ovarian Cancer
  • Phase I
  • cancer
  • solid tumors
  • advanced solid malignancies
  • NSCLC
  • epithelial ovarian cancer
  • dose escalation
  • combination treatment
  • src inhibitor
  • Japanese
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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