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Completed

NCT Number: NCT01813474

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

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.

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Key information

Conditions

Cancer Advanced Solid Malignancies Neoplasms

Age range

20 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Chūōku, Japan

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About this study

MTD - maximum tolerated dose

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olaparib

Drug

tablet oral

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From the start dose to 30 days after the last dose of study drug

    An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.

Secondary outcomes

  1. Number of Participants With Dose Limiting Toxicities

    Time frame: From the start dose to 28 days after the first dose of study drug

    Dose Limiting Toxicities were defined as study specific events that is determined to be possibly or probably related to olaparib (as determined by the investigator) and occurring during the first cycle of treatment (28 days after the first dose), irrespective of whether the toxicity resolved.

  2. Cmax Following Single Dosing

    Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose

  3. Cmax Following Multiple Dosing

    Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

  4. Tmax Following Single Dosing

    Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose

  5. Tmax Following Multiple Dosing

    Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

  6. AUC Following Single Dosing

    Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose

  7. AUC at Steady State Following Multiple Dosing

    Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2013
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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