| Date |
Broadcast |
| 5/24/2013 10:23:03 AM |
Subject: RTOG 1115 PROTOCOL NOTICE: SAFETY REPORTS FOR TAK-700
RTOG has received a safety report for TAK-700.
Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s).
The following RTOG study involves TAK-700:
RTOG 1115- Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer
The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
- Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
- File a copy of the IND Safety Report in your protocol file.
- 2012-08198_FU3_25Apr2013_INVL.pdf
|
| 5/21/2013 2:51:02 PM |
Subject: RTOG 0436, 0521, 0525, 0617, 0831, 0834, 0913, 0920, 0929, 1016 (Canadian sites only), 1115- Biologics, Inc Holiday Schedule
Biologics, Inc. will be closed Monday, May 27 in observance of Memorial Day
Their regular business hours are Monday through Friday, 9 a.m. to 6 p.m. ET.
If you have questions or need to coordinate shipments in advance, please don’t hesitate to contact your Clinical Research Project Manager at 800.693.4906.
Elliott Lee
Clinical Research Project Manager
Ext: 4990 |
| 5/3/2013 10:51:20 AM |
Subject: RTOG 1115 PROTOCOL NOTICE: SAFETY REPORTS FOR TAK-700
RTOG has received safety reports for TAK-700.
Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s).
The following RTOG study involves TAK-700:
RTOG 1115- Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer
The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
- Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
- File a copy of the IND Safety Report in your protocol file.
- 2013-02044_I_12Mar2013_INVL.pdf
- 2013-02278_I_18Mar2013_INVL.pdf
|
| 3/22/2013 10:32:31 AM |
Subject: RTOG 1115 PROTOCOL NOTICE: SAFETY REPORT FOR TAK-700
RTOG has received a safety report for TAK-700.
Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s).
The following RTOG study involves TAK-700:
RTOG 1115- Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer
The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
- Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
- File a copy of the IND Safety Report in your protocol file.
- 2012-08159_FU5_08Feb2013_INVL.pdf
|
| 3/1/2013 11:40:30 AM |
Subject: RTOG 1115 PROTOCOL NOTICE: SAFETY REPORTS FOR TAK-700
RTOG has received safety reports for TAK-700
Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s).
The following RTOG study involves TAK-700:
RTOG 1115- Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer
The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
- Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
- File a copy of the IND Safety Report in your protocol file.
- 2012-08974_FU2_27Dec2012_INVL.pdf
- 2012-04343_FU7_11Jan2013_INVL.pdf
- 2013-00133_FU2_11Jan2013_INVL.pdf
|
| 2/12/2013 1:37:13 PM |
Subject: RTOG 1115 PROTOCOL NOTICE: NEW TAK-700 Investigator Brochure now available on the website
A NEW Investigator Brochure for TAK-700, version 9 dated 7 December 2012, is now available on the RTOG website. This version replaces the previous version 8 dated 24 August 2011.
***The same username and password currently required to view all confidential materials on the RTOG website must be used to access Investigator Brochures*** |
| 2/5/2013 1:51:50 PM |
Subject: RTOG 1115, Updated
Updated
RTOG 1115, “Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer”
Cover Pages: ECOG has endorsed the study. Dr. Vapiwala was added as the ECOG co-chair, and CTSU contact information was added.
IRB review of an update is not required; however, these changes must be reported to site IRBs. |
| 12/27/2012 1:46:14 PM |
Subject: RTOG 1115 PROTOCOL NOTICE: SAFETY REPORT FOR TAK-700
RTOG has received a safety report for TAK-700
Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s).
The following RTOG study involves TAK-700:
RTOG 1115- Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer
The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
- Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
- File a copy of the IND Safety Report in your protocol file.
- 2012-06705_FU1_15Nov2012_INVL.pdf
|
| 12/12/2012 12:17:02 PM |
Subject: RTOG 0436, 0521, 0525, 0617, 0831, 0834, 0913, 0920, 0929, 1016 (Canada only), 1115- Biologics, Inc Holiday Schedule
Biologics, Inc. will be closed Monday and Tuesday, December 24 and 25, and Tuesday, January 1. Their regular business hours are Monday through Friday, 9 a.m. to 6 p.m. ET. If you have questions or need to coordinate shipments in advance, please do not hesitate to contact Clinical Trial Services at Biologics.
Elliott Lee
Clinical Trial Project Manager
Ext: 4990
Michael James, RPh, PhD
Director, Clinical Trial Services
Ext: 4961 |
| 11/20/2012 10:28:58 AM |
Subject: RTOG 0436, 0521, 0525, 0617, 0831, 0834, 0913, 0920, 0929, 1016 (Canada only), 1115- Biologics, Inc Holiday Schedule
In honor of Thanksgiving, Biologics, Inc. will be closed Thursday, November 22 and Friday, November 23. They will resume regular business hours on Monday, November 26.
Their regular business hours are Monday through Friday, 9 a.m. to 6 p.m. ET. If you have questions or need to coordinate shipments in advance, please do not hesitate to contact Biologics.
Elliott Lee
Clinical Trial Project Manager
Ext: 4990
Michael James, RPh, PhD
Director, Clinical Trial Services
Ext: 4961
|