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A new staff member has joined PMB! Eileen Wu received her Pharm.Ddegree from Rutgers the State University of New Jersey in 2007, and Eileenjoined the Children’s Hospital of Philadelphia where she first worked in thecentral pharmacy then transitioned to the Investigational Drug Service(IDS).  In the IDS, Eileen was responsible for reviewing protocols for theIRB, assisting investigators in developing protocols, and training thepharmacy staff and residents in the procedures for conducting andsupporting investigational drug protocols. She was also responsible fordispensing all investigational agents for inpatient and outpatient settings,providing patient counseling, and developing randomization schemes andplacebo controls for blinded studies. It is with a great deal of pleasure thatwe welcome Dr. Eileen Wu to the PMB staff.

PMB Investigational DrugAccountability - Next 3 Videos!

Cancer Therapy Eva lua t ion ProgramDiv i s ion o f Cancer Trea tment & D iagnos i s

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U.S. Department of Health and Human Services . National Institutes of Health . National Cancer Institute

New Videos are live at:

● Agent Dispensing(length 00:09:34)

● Patient-Specific DARFs(length 00:10:14)

● Agent Transfers(length 00:07:37)

These videos build off previouslyreleased videos:

● DARF Basics(length 00:05:05)

● DARF Header(length 00:04:33)

● Oral DARF(length 00:06:12)

● Agent Receipt(length 00:06:03)

Upcoming Changes toShipping ContainersIn the next few months, agents thatare shipped at room temperaturewill be sent from the NCI ClinicalRepository in new pre-qualifiedshipping containers. Thesecontainers will contain various typesof phase-change material tomaintain ambient or controlled-roomtemperature conditions as requiredfor the specific agent. Pleasealways refer to the agent productlabel for appropriate storageconditions upon receipt.

With this change, the NCI ClinicalRepository will only ship agent onMonday through Thursday todomestic sites (unless Saturdaydelivery is requested). There will beno ability to receive agents onMonday at domestic sites. Planaccordingly.

While our repository does anadmirable job of processingapproved clinical supply requestsfor sites as efficiently as possible,there is no guarantee that orderswill ship the same business day asthey are received. Normalprocessing time for routine ordersis two business days – this hasalways been our procedure and it isin the Policy and Guideline forInvestigational Agent Ordering onthe PMB Agent Managementwebsite at:

Any requests for next-day deliveryMUST be accompanied by asite-provided courier accountnumber to ensure next-daydelivery, regardless of the normalshipment mode for the agent.Please remember that all requestsfor next-day delivery must besubmitted before 2:00 p.m.Eastern Time.

Requests for Next-DayReceipt of Agent Orders

http://ctep.cancer.gov/branches/pmb/drug_training_videos.htm

http://ctep.cancer.gov/branches/pmb/agent_management.htm

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The handout discusses potentialinteractions between the agentand 1) isozymes responsible forthe biotransformation of manydrugs; and 2) transport proteins.It also comments on an agent’sability to affect the heart’selectrical activity (specifically QTcprolongation).

The Patient Drug InformationHandout and Wallet Cardresources are included as anappendix to the protocol.

As such, IRB approval is requiredprior to patient distribution.Spaces are available to insert thepatient’s name and the studycontact name and phone number.No other additions are necessary.

The PMB will update the handoutand wallet card as appropriate,based on information receivedfrom the company collaborator.Please note that once an agentbecomes commercially available,the handout and wallet card willno longer be maintained byCTEP.

Drug interaction information iscontained within the packageinsert of commercial agents.Therefore, CTEP will not create ormaintain Patient Drug InformationHandouts and Wallet cards forcommercially marketed agents.The PI may create an agentspecific handout and wallet cardor maintain the documents ifcurrently in the protocol.

The generic appendix template isavailable as Appendix C of theGeneric Protocol Template foundon the CTEP website.

Patient Drug InformationHandout and Wallet Card

Taking appropriate medications isessential in optimizing drugtherapy for patients who areparticipating in CTEP-sponsoredtrials. Potential drug-interactions(DDIs) are problematic and maybe complex to manage; thus, bothprescriber and patient needspecific drug information for theproper use of the drug to avoidDDIs .

For this reason, PMB proposesusing the Patient Drug Handoutand Wallet Card. Patients shouldkeep a copy with them at all timesand share it with their regulardoctor, nurses, pharmacist, orother healthcare professionals sothat the healthcare providers canmanage patients’ medicationsappropriately.

The location of drug interactioninformation in the protocoldocument has varied in the past.It may be in the body of theprotocol or in an appendix. Foruniformity, the PharmaceuticalManagement Branch (PMB) willprovide a Patient Drug InformationHandout and Wallet Card as anappendix for CTEP-held INDagents that are not FDAapproved.

The Patient Drug InformationHandout and Wallet Card is a twoto three page document specificto an investigational agent.

APPENDIX __: PATIENT DRUGINFORMATION HANDOUT ANDWALLET CARD

Information for Patients, TheirCaregivers and Non-Study HealthcareTeam on Possible Interactions withOther Drugs and Herbal Supplements

[Note to authors: This appendix consistsof an “information sheet” to be handed tothe patient at the time of enrollment. Useor modify the text as appropriate for thestudy agent, so that the patient is aware ofthe risks and can communicate with theirregular prescriber(s) and pharmacist. Aconvenient wallet-sized information card isalso included for the patient to clip out andretain at all times. If you choose to usethem, please note that the informationsheet and wallet card will require IRBapproval before distribution to patients.]

The patient___________________________ isenrolled on a clinical trial using theexperimental study drug, [insert study drugname]. This clinical trial is sponsored bythe National Cancer Institute. This form isaddressed to the patient, but includesimportant information for others who carefor this patient.

These are the things that you as ahealthcare provider need to know:

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Example:

http://ctep.cancer.gov/protocolDevelopment/templates_applications.htm

Example:

·   Patient enrollment involvestwo steps: screening andtreatment

·   Screening will involve 3,000tumor biopsy specimens

·   Treatment will involve about1,000 patients

·   Each  arm will  enroll  30evaluable patients

Because it is difficult to performmolecularly targeted clinical trialsexcept in the most prevalent typesof cancer, NCI-MATCH is designedto detect responses in varioustumor types, especially rarerhistologies. Such findings can befollowed up with additional clinicaltrials to learn more about the effectof the drug on patients whosetumors have the targeted mutation.The study will drop completed armsand add new arms over time, withupwards of 25 agents being testedin different arms. Study activation isexpected this summer. The first 10NCI-MATCH arms are listed in theTable 1.

EAY131, otherwise known as NCI-MATCH (NCI-Molecular Analysisfor Therapy Choice), is a multi-armclinical trial that will analyzepatients’ tumors to determinewhether they contain actionablemutations of interest. Treatment isassigned based on the actionablemutation with the overall objectiveof determining whether treatingcancers according to theirmolecular abnormalities is effective.ECOG-ACRIN Cancer ResearchGroup is coordinating the trialthrough the National Clinical TrialsNetwork (NCTN). Agents can onlybe ordered from the PMB when apatient is assigned to a specificarm. Starter supplies are notprovided for this study.Some quick facts about NCI-MATCH.

·   Up to 2,400 clinical sites inNCTN can enroll

·   Central  IRB  review  isrequired

NCI-MATCH Study to Open withTen Arms

Table 1

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Please note the NCI Clinical Repositorywill be closed on these federal holidays.

Please plan accordingly.

Up-coming federalholidays

For more information, visit:http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match

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Tables 2 & 3 highlight some of the relatively neweragents in the CTEP portfolio. Some may alreadybe used in active protocols. The complete list of allagents in the CTEP portfolio can be found on theCTEP website.

Please always refer to the most current versionof the protocol for up to date storage, shipping,dosage form, and drug interaction information.

PMB will be implementing a listserv called NCIDCTD-CTEP-PMB in the next couple of months.The purpose of this listserv is to provide a methodof communicating PMB news and announcementsto our customers in real time. This will include newissues of the Inside PMB Newsletter, newInvestigational Drug Accountability TrainingVideos, issues related to weather, holiday closurereminders, and other news. It is important to notethat the listserv does not replace our currentsystem of notifying relevant parties about criticalinformation such as stock recovery, protocol/INDstatus updates, and amendment requests.

Tabl

e 2

Tabl

e 3

New and OngoingCTEP-Agents Portfolio

Listserv - A New PMBCommunicationProcess

All current subscribers to the Inside PMB Newsletterwill be automatically added to the listserv. Anyoneinterested in subscribing to the listserv can find thelink to subscribe on our website when activated.

This listserv is for announcement only so pleasecontinue sending specific questions topmbafterhours@mail.nih.gov. We will make anannouncement to the listserv once the listserv andwebsite links are live.

http://ctep.cancer.gov/protocoldevelopment/docs/ctep_active_agreements.xlsx