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

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ClinicalTrials.gov Identifier: NCT01813474
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : December 12, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Malignancies Drug: olaparib Phase 1

Detailed Description:
MTD - maximum tolerated dose

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 25, 2013
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: olaparib tablet monotherapy
olaparib tablet
Drug: olaparib
tablet oral




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813474


Locations
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Japan
Research Site
Chuo-ku, Japan, 104-0045
Research Site
Fukuoka-shi, Japan, 811-1395
Research Site
Sapporo-shi, Japan, 003-0804
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Thomas Morris, M.D. Global Medicines Development

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01813474     History of Changes
Other Study ID Numbers: D081BC00001
First Posted: March 19, 2013    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: January 16, 2018
Last Verified: December 2017
Keywords provided by AstraZeneca:
Cancer
Tumour
Solid Malignancies
Additional relevant MeSH terms:
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Neoplasms
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents