Trial Summary Report and XML File Data Elements

2013-03

<verification_date>2013-03</verification_date>

Trial Category

Not included in the XML file

Trial Type

<study_type>Interventional</study_type>

NCI Trial Identifier

NCI-2011-9999

<id_info>
<secondary_id>
<id>NCI-2011-99999</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>CTRP (Clinical Trial Reporting Program)
</id_domain>
</secondary_id>
</id_info> 

ClinicalTrials.gov Identifier

Not included in the XML file

Lead Organization Identifier

<id_info>
<secondary_id>
<id>CCCCWFU 12345</id>
<id_type>
Other Identifier
</id_type>
<id_domain>Wake Forest University Health Sciences
</id_domain>
</secondary_id>
</id_info> 

DCP Identifier

WFU-01-01-06

<secondary_id><id>WFU-01-01-06</id></secondary_id>
<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>DCP
</id_domain>
</secondary_id>
</id_info> 

CTEP Identifier

WFU-01-01-06

<id_info>
<secondary_id>
<id> WFU-01-01-06</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>CTEP
</id_domain>
</secondary_id>
</id_info> 

CCR Identifier

Type

<study_type>Interventional</study_type>

Official Title

<official_title>A Phase II Double-Blind Feasibility Study of Armodafinil....</official_title>

Brief Title

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

<brief_title>Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors</brief_title>

Not included in the XML file

This clinical trial is studying how well Armodafinil works....

<brief_summary><textblock>
This clinical trial is studying how well Armodafinil works..../>
<textblock><brief_summary>

<detailed_description><textblock>
Detailed Description...
</textblock></detailed_description>

I. To estimate....

<detailed_description><textblock>
PRIMARY OBJECTIVES: I. To estimate....
<textblock><detailed_description>

I. To obtain a preliminary estimate....

<detailed_description><textblock>
SECONDARY OBJECTIVES: To obtain a preliminary estimate....
</textblock></detailed_description>

OUTLINE: This is a multicenter study....

<detailed_description><textblock>
OUTLINE: This is a multicenter study....
</textblock></detailed_description>

Keywords

<keyword>Feasibility Armodafinil</keyword>
<keyword>narcolepsy</keyword>

Reporting Dataset Method

Sponsor

National Cancer Institute

<sponsors>
<lead_sponsor>
<agency>National Cancer Institute</agency>
</lead_sponsor>
</sponsors>

Lead Organization

Wake Forest University Health Sciences

<overall_official>
<first_name>PI First Name</first_name>
<last_name>PI Last Name</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences </affiliation>
</overall_official>

Principal Investigator

Autissier, Isabelle affiliated with Wake Forest University Health Sciences in the role of Principal Investigator

<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>

Responsible Party

Sponsor

<resp_party_type>Sponsor</resp_party_type>

Overall Official

Autissier, Isabelle affiliated with  Wake Forest University Health Sciences in the role of Principal Investigator

<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>National Cancer Institute External</affiliation>
</overall_official>

Current Trial Status

Closed to Accrual and Intervention as of 08/01/2012

<overall_status>Active, not recruiting</overall_status>

Trial Start Date

08/01/2010-Actual

<start_date>2010-08</start_date>

Primary Completion Date

01/11/2014-Actual

<primary_compl_date>2014-01</primary_compl_date>
<primary_compl_date_type>Actual</primary_compl_date_type>

Completion Date

02/04/2014-Actual

Oversight Authorities

United States: Food and Drug Administration

<oversight_info>
<regulatory_authority>United States : Food and Drug Administration</regulatory_authority>
</oversight_info> 

FDA Regulated Intervention?

<is_fda_regulated>Yes</is_fda_regulated> 

Section 801?

<is_section_801>Yes</is_section_801> 

DMC Appointed?

<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info> 

IND/IDE Study?

<is_ind_study>Yes</is_ind_study>

Board Approval Status

Submitted, approved

<irb_info>
<approval_status>Approved</approval_status>
<irb_info>

Board Approval Number

IRB00012856

<irb_info>
<approval_number>IRB00012856</approval_number>

<irb_info>

Board

Wake Forest University Health Sciences

<irb_info>
<name>Wake Forest University Health Sciences</name>
<irb_info>

Affiliation

<irb_info>
<affiliation>Wake Forest University Health Sciences</affiliation>
<irb_info>

<ind_grantor>CBER</ind_grantor>

<ind_number>119999</ind_number>

Not included in the XML file

<has_expanded_access>Available</has_expanded_access>

NIH Grants > Funding Mechanism

<secondary_id><id>U10CA12345</id><id_type>NIH Grant Number</id_type></secondary_id><secondary_id>

NIH Grants > NIH Institution Code

<secondary_id>
<id>U10CA 012345</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

<secondary_id>
<id>U10CA8888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

Not included in the XML file

Data Table 4 Information > Funding Category

Externally Peer-Reviewed

Data Table 4 Information > Funding Sponsor/Source

National Cancer Institute

Prostate

National Cancer Institute

<collaborator>
<agency>National Cancer Institute</agency>
</collaborator>

Prostate Carcinoma

<condition>Prostate Carcinoma</condition>

Trial Design > Type

Interventional

<study_type>Interventional</study_type>
and

<study_design>Interventional</study_design>

Trial Design > Primary Purpose

Prevention

<study_design>
<interventional_design>
<interventional_subtype>Prevention</interventional_subtype>
</interventional_design>
</study_design>

Trial Design > Phase

<study_design>
<interventional_design>
<phase>II</phase>
</interventional_design>
</study_design>

Trial Design > Intervention Model

<study_design>
<interventional_design>
<assignment>Parallel Assignment</assignment>
</interventional_design>
</study_design>

Trial Design > Number of Arms

<study_design>
<interventional_design>
<number_of_arms>2</number_of_arms>
</interventional_design>
</study_design>

Trial Design > Masking

<study_design>
<interventional_design>
<masking>Double Blind</masking>
</interventional_design>
</study_design>

Trial Design > Allocation

Randomized Controlled Trial

<study_design>
<interventional_design>
<allocation>Randomized Controlled Trial</allocation>
</interventional_design>
</study_design>

Trial Design > Classification

<study_design>
<interventional_design>
<endpoint>Safety Efficacy Study</endpoint>
</interventional_design>
</study_design>

Trial Design > Target Enrollment

Eligibility Criteria > Accepts Healthy Volunteers?

No

<eligibility criteria >
<healthy_volunteers>No</healthy_volunteers>
</eligibility>

Eligibility Criteria > Gender

Both

<eligibility criteria >
<gender>Both</gender>
</eligibility>

Eligibility Criteria > Minimum Age

18 Years

<eligibility criteria >
<minimum_age>18 years</minimum_age>

Eligibility Criteria > Maximum Age

N/A

<eligibility criteria >
<maximum_age>N/A</maximum_age>
</eligibility>

NA

Eligibility Criteria > Inclusion Criteria

Family history of prostate cancer...

<eligibility>
<criteria>
<textblock>Inclusion Criteria: Family history of prostate cancer...</textblock>
</criteria>
</eligibility>

NA

Patient must not have had radiation therapy in the pelvic area....

<eligibility>
<criteria>
<textblock>Exclusion Criteria: Patient must not have had radiation therapy in the pelvic area....</textblock>
</criteria>
</eligibility> 

<intervention_type>Drug</intervention_type>

Armodafinil

<intervention_name>Armodafinil</intervention_name>

2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...

<intervention_other_name>2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...</intervention_other_name>

Given orally

<intervention_description><textblock>Given orally</textblock></intervention_description>

Placebo Comparator

<arm_type>Placebo Comparator</arm_type>

Arm II

<arm_group_label>Arm II</arm_group_label>

Patients receive oral Armodafinil once daily....

<arm_group_description>
<textblock>Patients receive oral Armodafinil once daily....</textblock>
</arm_group_description>

Accrual rate estimated as the number of patients ....

<primary_outcome>
<outcome_measure>Accrual rate estimated as the number of patients ....</outcome_measure>
</primary_outcome>

<outcome_description>
<textblock>Estimated using an analysis of covariance (ANCOVA) model which includes....</textblock>
</outcome_description>

<outcome_time_frame>Up to 2 years</outcome_time_frame>

Incidence of toxicity incidents....

<secondary_outcome>
<outcome_measure>Incidence of toxicity incidents assessed....</outcome_measure>
<secondary_outcome>

<outcome_description>

<outcome_time_frame>Up to 2 years</outcome_time_frame>

<outcome_safety_issue>No</outcome_safety_issue>

Sub-groups Stratification Criteria > Label

Not included in the XML file

Sub-groups Stratification Criteria > Description

Not included in the TSR

Not included in the XML file

Markers > Marker Name

Not included in the TSR

Not included in the XML file

Markers > Evaluation Type

Not included in the TSR

Not included in the XML file

Markers > Assay Type

Not included in the TSR

Not included in the XML file

Markers > Biomarker Use

Not included in the TSR

Not included in the XML file

Markers > Biomarker Purpose

Not included in the TSR

Not included in the XML file

Markers > Specimen Type

Not included in the TSR

Not included in the XML file

Wake Forest University Health Sciences

Winston-Salem, NC 27106

United States

<location>
<facility>
<name> Wake Forest University Health Sciences </name>
<address>
<city>Winston-Salem</city>
<state>NC</state>
<zip>27106</zip>
<country>United States</country>
</address>
</facility>
</location> 

Autissier, Isabelle, M.

phone:123-123-1234

Email:ia@domain.com

<location>
<contact>
<first_name>Isabelle</first_name>.<middle_name>M</middle_name><last_name>Autissier</last_name>
<phone>123-123-1234></phone>
<email>ia@domain.com</email>..
</ contact>
</location>        

Enrolling by Invitation as of 05/09/2014

<location>
<status>Enrolling by Invitation</status>
</location>

<investigator>
<first_name>Isabelle</first_name><last_name>Autissier</last_name><role>Principal Investigator</role>
</investigator>