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83403

A Phase II Study of Single Agent Depsipeptide (FK228) in
Recurrent, Platinum Sensitive Adeno-Carcinoma of the Ovary or Peritoneum


Study officially closed to accrual for all sites effective 01/18/06 and terminated as of 03/28/07.


Archived Amendments  l  Appendices  l  Annual Renewals: See below

CCCWFU CCOP Research Base

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Archived Amendments 

PDF Format Protocol

Consent Forms (Stamped and MS Word) 

List of Changes

Appendices

IRB Approval Letter

 

 

 

 

 

Termination

 

 

 

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Termination Approval

image001_1993101563

Am7

No new consent.  Please refer to Am6 version below.

image001_1993101564

Am7 changes

Appendices are located at the bottom of the screen.

image001_1993101565

Am7 IRB approval

image001_1993101566

Am6

image001_1993101567

07/27/05

Am6 stamped consent

 

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Am6 consent MS Word

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Am6 changes

Appendices are located at the bottom of the screen.

image001_1993101569

Am6 IRB approval

image001_19931015691

Am5

No new consent.  Please refer to Am2 version below.

image001_19931015692

Am5 changes

Appendices are located at the bottom of the screen.

image001_19931015693

Am5 IRB approval

image001_19931015694

Am4

No new consent.  Please refer to Am2 version below.

 

image001_19931015695

Am4 changes

 

Appendices are located at the bottom of the screen.

image001_19931015696

Am4 IRB approval

image001_19931015697

Am3

No new consent.  Please refer to Am2 version below.

 

image001_19931015698

Am3 changes

Appendices are located at the bottom of the screen.

image001_19931015699

Am3 IRB approval

image001_199310156991

Am2

image001_199310156992

09/22/04

Am2 consent stamped

 

image008

Am2 consent MS Word

image001_199310156993

Am2 changes

Appendices are located at the bottom of the screen.

image001_199310156994

Am2 IRB approval

 

image001_199310156995

Am1

image001_199310156996

07/28/04

Am1 stamped consent

 

image009

Am1 consent MSWord

 

 

image001_199310156997

Am1 changes

Appendices for this protocol are located at the bottom of the screen.

image001_199310156998

Am1 IRB approval

image001_199310156999

Initial protocol

image001_1993101569991

07/08/04

Initial stamped consent

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Initial consent MSWord

 

 

Appendices for this protocol are located at the bottom of the screen.

image001_1993101569992

Initial IRB approval

Appendices

image001_1993101569993

Combined Appendices

06/29/05

 

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Appendix A Data Submission Checklist

04/14/05

 

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Appendix B Performance Status Criteria

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Appendix C New York Heart Assoc. Classifications

image001_1993101569997

 Appendix D Medications that May Cause QT Prolongation

image001_1993101569998

Appendix E Eligibility Checklist and Registration Form

06/29/05

 

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Appendix F Depsipeptide Treatment Form

01/19/05

 

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Appendix G Toxicity Reporting Form

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Appendix H Depsipeptide Tumor Evaluation Form

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Appendix I Depsipeptide Treatment Completion Form

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Appendix J Remarks Addenda

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Appendix K Off-Treatment Follow-Up Form

image001_19931015699996

Appendix L Cardiac Monitoring Guidelines

 image001_19931015699997

Appendix M VEG-F and Tissue Sample

09/27/04

image001_19931015699998 

Appendix N NIH Form 986

 image0092

83403 WFU HIPAA Form

 

 2005 Continuing Renewal

 image001_19931015699999

2005 Annual Renewal IRB Approval

 

image001_199310156999991

2005 Annual Renewal Consent

 

 

 

 

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Last Modified: 1/29/2009