Trial record 1 of 1 for:    pcI-27483
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Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

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. Identifier: NCT01020006
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : April 2, 2014
Last Update Posted : April 24, 2014
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pancreatic Cancer
Ductal Adrenocarcinoma
Exocrine Pancreatic Cancer
Interventions: Drug: PCI-27483
Drug: Gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
PCI-27483 + Gemcitabine/Part A Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
PCI-27483 + Gemcitabine/Part B Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
Gemcitabine/Part B Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Participant Flow:   Overall Study
    PCI-27483 + Gemcitabine/Part A   PCI-27483 + Gemcitabine/Part B   Gemcitabine/Part B
STARTED   8   18   16 
COMPLETED   0 [1]   0 [1]   0 [1] 
NOT COMPLETED   8   18   16 
[1] No subjects reached study completion as defined by protocol.

  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.
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Reporting Groups
(PCI-27483 + Gemcitabine)/Part A No text entered.
(PCI-27483 + Gemcitabine)/Part B No text entered.
Gemcitabine/Part B No text entered.
Total Total of all reporting groups

Baseline Measures
   (PCI-27483 + Gemcitabine)/Part A   (PCI-27483 + Gemcitabine)/Part B   Gemcitabine/Part B   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   18   16   42 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   5   13   10   28 
>=65 years   3   5   6   14 
[Units: Participants]
Female   4   7   6   17 
Male   4   11   10   25 
Region of Enrollment 
[Units: Participants]
United States   8   18   16   42 

  Outcome Measures

1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B). ]

  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
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  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: Dr. Laurence Elias
Organization: Pharmacyclics
phone: 855-427-8846

Responsible Party: Pharmacyclics LLC. Identifier: NCT01020006     History of Changes
Other Study ID Numbers: PCYC-1001
First Submitted: November 20, 2009
First Posted: November 25, 2009
Results First Submitted: February 18, 2014
Results First Posted: April 2, 2014
Last Update Posted: April 24, 2014