Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

Sponsor
AstraZeneca
Study ID
NCT01813474
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Malignancies
  • Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

Key Dates

Start date
Mar 25, 2013
Status verified
Dec 2017
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib tablet monotherapy
    olaparib tablet

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From the start dose to 30 days after the last dose of study drug ]

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