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A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Cancer, Advanced Solid Malignancies

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Trial Information

A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies


MTD - maximum tolerated dose


Inclusion Criteria:



- Subjects diagnosed with advanced solid malignancies who are refractory to standard
therapies or for which no standard therapy exists.

- Subjects who have overall good overall general condition.

- Subjects who agree to hospitalisation from starting olaparib to multiple dose period
at day 15.

- Evidence of non-childbearing status for women of childbearing potential, or
postmenopausal status.

- Subjects who have at least one lesion (measurable and/or non-measurable) that can be
accurately assessed by CT/MRI at baseline and follow up visits

Exclusion Criteria:

- Subjects who received any previous treatment with a PARP (poly adenosine
diphosphate-ribose polymerase) inhibitor, including olaparib.

- Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).

- Subjects with symptomatic uncontrolled brain metastases.

- Subjects with myelodysplastic syndrome/acute myeloid leukaemia.

- Subjects with a known hypersensitivity to olaparib or any of the excipients of the
product.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Investigation of the safety and tolerability of olaparib tablet by assessing of CTCAE (Common Terminology Criteria Adverse Events) grade in Japanese patients with advanced solid malignancies.

Outcome Time Frame:

Up to 11 months.

Safety Issue:

No

Principal Investigator

Anitra Fielding, M.B.

Investigator Role:

Study Director

Investigator Affiliation:

Global Medicines Development

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D081BC00001

NCT ID:

NCT01813474

Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Cancer
  • Advanced Solid Malignancies
  • Cancer
  • Tumour
  • Solid Malignancies
  • Neoplasms

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