1. Synta Pharmaceuticals 9090-08
Virginia Castillo

2. Agenda BARC Project Team Central laboratory services
Central laboratory approach
Material flow chart
Trial-specific material
Sample handling
Shipping of samples
Data integrity
Reporting

3. BARC Project team Virginia Castillo Project Manager 516 719 1040
Jennifer Camejo
Project Manager

4. Central lab services
Investigator/Monitor information (manual & leaflets)
Supplies (sampling & shipping materials)
Sample shipment
Sample analysis
Sample storage
Data management
Customized reporting
Technical support

5. Central lab approach Ambient shipment to BARC Frozen shipment to BARC
LDH
LDH isoforms
Archived tissue/blocks
Frozen shipment to BARC PK
Pharmacogenetics (PG)
Biomarkers

6. Study flow chart TESTS TO BE PERFORMED AT BARC X
Laboratory tests:
Screening
Treatment Period
Within 4 Weeks of randomiza -tion
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 5
Cycle _
Day 1 (± 3 days)
Day 15 (± 3 days)
TESTS TO BE PERFORMED AT BARC
LDH X
LDH isoforms
TESTS TO BE PERFORMED BY THIRD PARTY LAB
PK sampling
Pharmacogenet -ics (PG) sampling
Biomarkers
Archived Tissue

7. TESTS TO BE PERFORMED BY THIRD PARTY LAB
Study flow chart – PK sampling
Tests
Treatment Period
Cycle 1
Cycle 2
Day 1 (± 3 days)
prior to ganetespib infusion termination(EOI)*
prior to docetaxel infusion termination (EOI)*
prior to ganetespib infusion termination (EOI)*
prior to docetaxel infusion termination (EOI)*
TESTS TO BE PERFORMED BY THIRD PARTY LAB
PK Sampling: Arm A (Docetaxel only): X
PK Sampling: Arm B (Ganetespib + Docetaxel):
* EOI = End of Infusion

8. SAMPLES TO BE SHIPPED AMBIENT TO BARC 1
Material needed:
Tests
Scr
Treatment Period
Within 4 Weeks of randomiza tion
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 5
Cycle _
Day 1
(± 3 days)
Day (± 3 days)
Day (± 3 days)
Day (± 3 days)
Day (± 3 days)
SAMPLES TO BE SHIPPED AMBIENT TO BARC
SST tube 8.5 mL (marble/brown stopper)*
LDH,
LDH Isoforms 1
Large brown cap cryovial 5 mL
LDH
Clear cap cryovial 5 mL
Red cap cryovial 5 mL (back-up)
LDH/LDH Isoforms
Paraffin blocks (histocassette) and/or a minimum of 10 Slides.
Archived Tissue
SAMPLES TO BE SHIPPED FROZEN TO BARC
Sodium Heparin tube 6 mL (green stopper)**
PK sampling
1 or 2
Blue cap cryovial 2 mL (Aliquot A)
1 or 2x2
Red cap cryovial 2 mL (Aliquot B)
K2EDTA tube 6 mL
(violet stopper)
PG sampling
Biomarkers
Orange cap cryovial 2 mL (Aliquot A)-
from Sodium Heparin tube 6 mL
Violet cap cryovial 2 mL (Aliquot B)-
K2EDTA tube 6 mL (violet stopper)**
Green cap cryovial 2 mL (Aliquot A)-
from K2EDTA tube 6 mL
Clear cap cryovial 2 mL (Aliquot B)-

9. Trial specific material – STUDY DOCUMENTS
Central lab Manual
Use of Requisition Form- label sheet
Description of tests to be carried out
Supplies provided and procedure to re-order supplies through Sample Material Request Form (SMRF) + semi automatic resupply (order proposal every 6 months)
Sampling procedures and sample management
Transport of samples to central lab (courier contact)
Analysis and reporting
Lab accreditation certificate & reference ranges

10. Trial specific material – STUDY DOCUMENTS
Instruction Leaflet
In local language
Summary of procedures with comprehensive pictograms (per visit)

11. Trial specific material – STUDY DOCUMENTS
REQUISITION FORM
Collection of subject demographic and visit data
Identification of various samples drawn
‘Error-proof’: all labels must be used to complete visit
Use one form per subject and per visit day
Apply barcode labels length wise
Every requisition form has a unique requisition #
Send original requisition form along with the samples
to BARC.

12. To be completed per subject
Trial specific material – STUDY DOCUMENTS
Sample log form
Log of all samples taken per patient
To be completed per subject
Labels with unique requisition number should come here (=link between subject and requisition number used)
SHOULD BE KEPT ON SITE!

13. Trial specific material – STUDY DOCUMENTS
sample material request form
Fill out SMRF and fax to or to
Re-supply shipping Procedure
Re-supply shipments will be shipped within 5 business days after receipt of the order.

14. Trial specific material – STUDY DOCUMENTS
EXAMPLE

15. Trial specific material – supplies
Visit specific kits
Local handling
Pipettes and transfer vials
Shipment and storage material
Pre-printed AWB, silver blue box
Ambient white Gel packs (do not freeze or referigerate)
Storage boxes (grid)
All IATA compliant
EXCLUSIVELY use BARC SUPPLIES

16. Trial specific material – supplies
Initial supplies
Continuation supplies
Use Sampling Material Request
Form or at:
and

17. Sample Handling - Ambient
LDH and LDH ISOFORMS
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. The SST tube need to site in an upright position for 30 minutes after inversion and before centrifugation.

18. Sample Handling - Ambient
Tumor tissue slides

19. Sample Handling - Frozen
Pharmacogenetics (PG) sampling
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. No further processing required.

20. Sample Handling - Frozen
PK sampling ARM A (Docetaxel)
Cycle 1/DAY 1/EOI and Cycle 2/DAY 1/EOI
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. Centrifuge within 1 hour of sampling.

21. PK sampling ARM B (Ganetespib + Docetaxel)
Sample Handling - Frozen
PK sampling ARM B (Ganetespib + Docetaxel)
Cycle 1/DAY 1/EOI and Cycle 2/DAY 1/EOI
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. Centrifuge within 1 hour of sampling.

22. Sample Handling - Frozen
Biomarker sampling
Immediately after obtaining the blood specimens, invert the tubes 8 to 10 times. Centrifuge within 1 hour of sampling.

23. Shipping of samples - general
Subject is best seen in the morning to ensure timely pick-up of the samples
Call local courier at telephone number provided by BARC within call hours (info sticker present on manual + leaflet)
Make sure all samples in all boxes are properly labeled and original requisition form is added to box

24. Shipping of samples -general
Courier is prepaid by BARC (BARC account number on Air Waybill)
Ambient shipments (day of collection)
Monday through Friday
Frozen shipments (monthly dry ice shipments)
Monday through Wednesday
Shipments cannot be made on the day before Local Public Holidays or on Local Public Holidays.

25. Shipment of Samples – Ambient shipment

26. Shipment of Samples – Frozen shipment

27. Shipment of Samples – Combined shipment

28. Data Integrity
In order to comply with GCP, any omission or inconsistency will be queried with a Data Clarification Form
The DCF must be resolved promptly and returned by fax to BARC

29. Reporting
Fax/ reports with LDH results to site within 24 hrs after reception
Cumulative reporting (up to two visits)
Missing results are coded: ‘N D’ « Not done » or ‘N R’ « Not received »

30. Reporting
Out of range values will be flagged with asterix (*) and evaluation box which needs scoring by investigator (CS/NCS)

31. xx/xx/xxxx
Editor: Presentation name here