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Trial record 66 of 854 for:    tablet | Japan

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer
Advanced Solid Malignancies
Intervention: Drug: olaparib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled on 25 March 2013. Last patient enrolled on 31 October 2013. Data cut off on 31 July 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 28 participants gave informed consent to join this study. Five participants were screen failures so that 23 participants were assigned and received study treatment

Reporting Groups
  Description
200 mg Bid, Dose Escalation Part Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg Bid, Dose Escalation Part Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg Bid, Expansion Part Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Participant Flow:   Overall Study
    200 mg Bid, Dose Escalation Part   300 mg Bid, Dose Escalation Part   300 mg Bid, Expansion Part
STARTED   4   7   12 
COMPLETED   1 [1]   0   1 [1] 
NOT COMPLETED   3   7   11 
Withdrawal by Subject                0                0                1 
Adverse Event                1                1                0 
Lack of Efficacy                2                6                9 
Death                0                0                1 
[1] ongoing study at final data cut off



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
200 mg Bid, Dose Escalation Part Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg Bid, Dose Escalation Part Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg Bid, Expansion Part Olaparib tablet 300 mg bid, 600 mg/day, expansion part
Total Total of all reporting groups

Baseline Measures
   200 mg Bid, Dose Escalation Part   300 mg Bid, Dose Escalation Part   300 mg Bid, Expansion Part   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   7   12   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.0  (8.68)   55.4  (8.98)   57.3  (12.43)   54.1  (11.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Sex         
Female      4 100.0%      4  57.1%      7  58.3%      15  65.2% 
Male      0   0.0%      3  42.9%      5  41.7%      8  34.8% 
Primary tumour location 
[Units: Participants]
Count of Participants
       
Breast      1  25.0%      1  14.3%      3  25.0%      5  21.7% 
Colorectal      0   0.0%      0   0.0%      1   8.3%      1   4.3% 
Lung      0   0.0%      1  14.3%      2  16.7%      3  13.0% 
Peritoneum      0   0.0%      0   0.0%      1   8.3%      1   4.3% 
Pancreas      0   0.0%      1  14.3%      0   0.0%      1   4.3% 
Ovary      0   0.0%      2  28.6%      2  16.7%      4  17.4% 
Uterus      1  25.0%      1  14.3%      0   0.0%      2   8.7% 
Cervix      2  50.0%      0   0.0%      0   0.0%      2   8.7% 
Colon      0   0.0%      0   0.0%      1   8.3%      1   4.3% 
Gastric Antrum      0   0.0%      0   0.0%      1   8.3%      1   4.3% 
Other      0   0.0%      1  14.3%      1   8.3%      2   8.7% 


  Outcome Measures

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

2.  Secondary:   Number of Participants With Dose Limiting Toxicities   [ Time Frame: From the start dose to 28 days after the first dose of study drug ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01813474     History of Changes
Other Study ID Numbers: D081BC00001
First Submitted: March 15, 2013
First Posted: March 19, 2013
Results First Submitted: July 6, 2017
Results First Posted: December 12, 2017
Last Update Posted: January 16, 2018