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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2013
First Posted Date  ICMJE March 19, 2013
Results First Submitted Date  ICMJE July 6, 2017
Results First Posted Date  ICMJE December 12, 2017
Last Update Posted Date January 16, 2018
Actual Study Start Date  ICMJE March 25, 2013
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
  • 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. [ Time Frame: Up to 11 months. ]
  • Investigation of the safety and tolerability of olaparib tablet by assessing of frequency of adverse events in Japanese patients with advanced solid malignancies. [ Time Frame: Up to 11 months. ]
Change History Complete list of historical versions of study NCT01813474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
Evaluation of pharmacokinetics of olaparib (Cmax, Tmax, AUC - area under curve). [ Time Frame: At day 1 and 2 single dose period, day 1 and 15 multiple dose period day. ]
Day 1 and 2 single dose period. Day 1 and 15 multiple dose period day. Pre dose of single dose period day 1 at: 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12h,day 2 at 24h and day 3 at 48h (same day as multiple dose period day 1). Pre dose of multiple dose period day 15 at: 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8h and 12h
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Official Title  ICMJE A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
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.
Detailed Description MTD - maximum tolerated dose
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Advanced Solid Malignancies
Intervention  ICMJE Drug: olaparib
tablet oral
Study Arms  ICMJE Experimental: olaparib tablet monotherapy
olaparib tablet
Intervention: Drug: olaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2013)
18
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01813474
Other Study ID Numbers  ICMJE D081BC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Morris, M.D. Global Medicines Development
PRS Account AstraZeneca
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP