Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01296763
First received: January 21, 2011
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: December 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Irinotecan
Drug: Cisplatin
Drug: Olaparib (for levels 1 and 5)
Drug: Olaparib (for dose level 2)
Drug: Mitomycin-C

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dose Level 1
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
Dose Level 2
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
Dose Level 5
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8

Participant Flow:   Overall Study
    Dose Level 1     Dose Level 2     Dose Level 5  
STARTED     7     5     6  
COMPLETED     7     5     6  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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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.
Subject with advanced pancreatic cancer

Reporting Groups
  Description
Dose Level 1
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
Dose Level 2
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
Dose Level 5
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level 2     Dose Level 5     Total  
Number of Participants  
[units: participants]
  7     5     6     18  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     7     3     5     15  
>=65 years     0     2     1     3  
Age  
[units: years]
Mean (Full Range)
  59.28  
  (47.31 to 65.81)  
  59.08  
  (33.09 to 72.9)  
  51.98  
  (38.73 to 76.48)  
  56.79  
  (33.09 to 76.48)  
Gender  
[units: participants]
       
Female     3     4     2     9  
Male     4     1     4     9  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     0     0     1     1  
Not Hispanic or Latino     7     5     5     17  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     1     1  
White     7     5     5     17  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     7     5     6     18  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)   [ Time Frame: 2 years ]

2.  Secondary:   Number of Years From Cycle 1, Day 1 On-Study to Date of Death   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The P.I. and Astrazeneca decided not to move forward with the Phase II part of the study. Therefore the arms of Irinotecan, Cisplatin, Mitomycin C with Olaparib versus Irinotecan, Cisplatin, Mitomycin C without Olaparib will not be compared.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas Brown
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: 410-502-5328
e-mail: tbrown55@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01296763     History of Changes
Other Study ID Numbers: J1070
RC2CA148346-01 ( US NIH Grant/Contract Award Number )
NA_00032826 ( Other Identifier: JHMIRB )
Study First Received: January 21, 2011
Results First Received: December 4, 2015
Last Updated: February 19, 2016
Health Authority: United States: Food and Drug Administration