NiCCC (G143)
(ENGOT-GYN1)
A Randomised Phase II study Of Nintedanib (BIBF1120)
Compared To Chemotherapy in Patients With Recurrent Clear
Cell Carcinoma Of The Ovary Or Endometrium
EudraCT Number:2013-002109-73
Protocol Number: NiCCC2013
ISRCTN50772895
PHARMACY INITIATION SLIDES
(Version 1.0 , 25th July 2014)
Trial Details
•
The trial is an NCRN/Boehringer Ingelheim (BI), collaboration
•
The trial is being co-ordinated via the Cancer Research UK Clinical Trials Unit, Glasgow
•
Sponsor of the trial is Greater Glasgow Health Board (GGHB)
•
The trial will also open across Europe via collaborations with the EORTC, the NSGO and
ARCAGY-GINECO
•
The Chief Investigator is Dr Ros Glasspool of the Beatson West of Scotland Cancer Centre.
The International Chief Investigator is Dr Mansoor Mizra of Copenhagen University Hospital
•
The trial is being funded by an educational grant from Boehringer Ingelheim (who are also
providing drug supply of Nintedanib) and is endorsed by CTAAC (Cancer Research UK)
*******************************************************************
Please note this presentation has been prepared as part of your site initiation training. These
slides are a compliment to the protocol, all site staff must have read and understood the protocol
and the trial requirements prior to signing off the initiation acknowledgment sheet
*******************************************************************
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Trial Team
•
Chief Investigator :
Dr Ros Glasspool
•
International Chief Investigator:
Dr Mansoor Mizra
•
Co-Investigator/
Translational Research Co-ordinator:
Professor Ian McNeish
•
Trial Statistician:
Jim Paul
•
Project Manager:
Claire Lawless
•
Pharmacovigilance:
Lindsey Connery / Susannah Redford
•
Clinical Trial Coordinator:
Laura Douglas
•
Clinical Trial Monitor:
Calum Innes
•
Sponsor Pharmacist
Dr Samantha Carmichael
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Pharmacy Initiation
• Protocol and treatment overview
• IMP presentation and management
• NiCCC IMP Stock Control Application
• Site initiation process
• Post site activation and monitoring arrangements
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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PROTOCOL & TREATMENT OVERVIEW
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Population and Aims
Trial population
• 120 patients with progressive or recurrent ovarian clear cell carcinoma, or
progressive or recurrent endometrial clear cell carcinoma. The primary diagnosis
must be histologically confirmed and central pathological review of the presenting
tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma
with no serous differentiation
Trial Aims
Primary Objective:
• The primary endpoint for efficacy is progression free survival as defined by RECIST
1.1 criteria. Progression free survival (PFS) is defined as the duration of time from
date of randomisation to date of progression or death, which ever occurs earlier
Secondary Objectives:
• Includes:
– Overall survival (OS)
– Disease Control Rate
– Toxicity
– Quality of Life.
– Q-TWiST (Quality-Adjusted Time Without Symptoms of Disease or Toxicity of
Treatment)
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Trial Eligibility
Inclusion Criteria:
1.
Progressive or recurrent ovarian clear cell carcinoma, or progressive or recurrent endometrial
clear cell carcinoma. The primary diagnosis must be histologically confirmed and central
pathological review of the presenting tumour or biopsy of relapsed disease must find at least
50% clear cell carcinoma with no serous differentiation. Progressive disease as defined by
RECIST 1.1
2.
Failure after ≥1 prior platinum containing regimen which may have been given in the adjuvant
setting. For patients with ovarian clear cell carcinoma, progression must have occurred within 6
months of their last platinum dose
3.
ECOG Performance status of ≤2
4.
Life expectancy of >3 months
5.
Adequate hepatic, bone marrow coagulation and renal function
-Hepatic function: total bilirubin within normal limits; ALT and AST < 2.5 x ULN
-Coagulation parameters: INR <2 x ULN and prothrombin time and activated partial
thromboplastin time < 1.5 x ULN in the absence of therapeutic anticoagulation
-Absolute neutrophil count (ANC) ≥1.5 x 109/L
-Platelets ≥ 100 x 109L
-Haemoglobin ≥ 9.0 g/dL
-Proteinuria < grade 2 (CTCAE version 4)
-Glomerular Filtration Rate ≥40ml/min. (calculated using Cockroft & Gault equation or
measured by EDTA clearance)
6.
Female and > 18 years of age
7.
Signed and dated written informed consent prior to admission to the trial in accordance with
ICH-GCP guidelines and local legislation.
8.
Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests
and other trial procedures.
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Trial Eligibility
Exclusion Criteria:
1.
Prior treatment with Nintedanib or other angiogenesis inhibitor/VEGF targeted therapy, except for
prior treatment with bevacizumab which is permitted
2.
Treatment within 28 days prior to randomisation with any investigational drug, radiotherapy,
immunotherapy, chemotherapy, hormonal therapy or biological therapy Palliative radiotherapy may
be permitted for symptomatic control of pain from bone metastases in extremities, provided that the
radiotherapy does not affect target lesions, and the reason for the radiotherapy does not reflect
progressive disease
3.
Previous treatment with the chemotherapy regimen selected as the control arm by the investigator.
(Prior therapy with paclitaxel given on a three weekly regimen is permitted for patients receiving
weekly Paclitaxel)
4.
Other malignancy diagnosed within 5 years of enrolment except for:
a)
Non-melanomatous skin cancer (if adequately treated)
b)
Cervical carcinoma in situ (if adequately treated)
c)
Carcinoma in situ of the breast (if adequately treated)
d)
For patients with ovarian clear cell cancer, prior or synchronous endometrial cancer (if
adequately treated), provided all of the following criteria are met:
•
Disease stage FIGO Stage 1a (tumour invades less than one half of myometrium)
•
Grade 1 or 2
5.
Patients with any other severe concurrent disease, which may increase the risk associated with trial
participation or trial drug administration and, in the judgement of the investigator, would make the
patient inappropriate for entry into this trial, including significant neurologic, psychiatric, infectious,
hepatic, renal, or gastrointestinal diseases or laboratory abnormality
6.
Symptoms or signs of gastrointestinal obstruction requiring parenteral nutrition or hydration or any
other gastro-intestinal disorders or abnormalities, including difficulty swallowing, that would interfere
with drug absorption
7.
Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral
therapy, including known hepatitis B and/or C infection and HIV-infection
8.
Symptomatic CNS metastasis or leptomeningeal carcinomatosis
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Trial Eligibility
Exclusion Criteria continued:
9. Known, uncontrolled hypersensitivity to the investigational drugs or their excipients
10. Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac
arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomisation, congestive
heart failure > NYHA III, severe peripheral vascular disease or clinically significant pericardial effusion
11. History of major thromboembolic event defined as:
• pulmonary embolism (PE) within six months prior to randomisation
• recurrent pulmonary embolism (history of at least 2 events)
• history of at least 2 unprovoked (=without a transient reversible risk factor) events of proximal deep
venous thrombosis
• history of a provoked (=with transient or reversible risk factor, such as surgery) thrombosis of
proximal deep veins or visceral vessels within 6 months prior to randomisation if not on stable
therapeutic anticoagulation
12. Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including
deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation or prothrombin
G20210A mutation)
13. Known inherited predisposition to bleeding or thrombosis
14. History of a cerebral vascular accident, TIA or subarachnoid haemorrhage within the past 6 months
15. History of clinically significant haemorrhage in the past 6 months
16. Major injuries or surgery within the past 28 days prior to start of trial treatment with incomplete wound
healing and/or planned surgery during the on-treatment trial period
17. Pregnancy or breastfeeding. Patients with preserved reproductive capacity must have a negative
pregnancy test (β-HCG test in urine or serum) prior to commencing trial treatment
18. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of
contraception for the duration of the trial and for 3 months afterwards
19. Radiographic evidence of cavitating or necrotic tumours with invasion of adjacent major blood vessels
20. Any psychological, familial, sociological or geographical consideration potentially hampering compliance
with the trial protocol and follow up schedule; those considerations should be discussed with the patient
before registration in the trial
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Trial Restrictions
•
•
•
•
•
•
•
•
•
Additional chemo-, immuno-, hormone- or radiotherapies are not allowed during except for
palliative radiotherapy for symptomatic control of pain from bone metastases in extremities. To be
discussed with CI.
Treatment < 28 days prior to randomisation with any investigational drug is not permitted.
Patients must not be recruited to any IMP trials that involve an IMP while on NiCCC protocol
treatment, and during the follow up period prior to recurrence.
Debulking surgery is not permitted on the trial prior to progression.
Any invasive procedures such as minor or major surgery should be postponed to at least 4 weeks
after the end of treatment with Nintedanib.
For urgent interventions, Nintedanib should be interrupted 2 weeks prior to the procedure and
not be started before wound healing is complete.
If patients require emergency surgery, Nintedanib should be stopped as soon as the procedure is
planned and, if possible, at least 48 hours prior to the procedure.
Concomitant therapy with the 5-HT3 receptor antagonists tropisetron and/or dolasetron which are
metabolized by cytochrome 2D6 should be avoided in patients on Nintedanib since they may lack
efficacy in patients who are ‘fast metabolizers’.
During treatment with Nintedanib, all trial patients will be advised to avoid sun exposure or
artificial UVA/UVB radiation in solaria or tanning booths. If exposure to sunlight cannot be avoided,
protective clothing and broad spectrum (UVA/UVB) sunscreens should be used. After
discontinuation of Nintedanib treatment all protective measures should be continued for at least 2
weeks
10
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
Trial Design
A multi-centre, randomised, open label phase II trial
90 patients with progressive or recurrent clear cell ovarian and up to 30 patients
with clear cell endometrial cancer
Registration
Central Pathology Review Criteria
and Eligibility Criteria met
Randomisation
Control Arm
Experimental Arm
Physicians choice of standard chemotherapy,
from list below*.
Nintedanib 200mg BD continuously until progression or
withdrawal from trial
Assessments
Assessments
Clinical:
At screening, Day 1 of each course of chemotherapy
CA125:
At screening and day 1 of each cycle during treatment then every 8
weeks until progression
CT Scans
Screening, and every 8 weeks until week 48 or until progression
Clinical:
At screening, Day 1 and then every 4 weeks until week 24
and then every 8 weeks.
CA125:
At screening, day 1 and every 4weeks until week 24 then
every 8 weeks until progression
CT Scans
Screening, and every 8 weeks until week 48 or until
progression
Primary Endpoint: PFS
Secondary Endpoints: OS, QoL, QTWIST, ORR, & DCR at 12 weeks
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Treatment and Duration
•
Experimental Arm
Nintedanib (BIBF1120) 200mg twice daily PO, continuously, until progression
or withdrawal from the treatment.
•
Control Arm
The chemotherapy regimen will be physician’s choice from the list below.
The planned regimen (if allocated to the control arm) must be declared prior
to randomisation:
•
Ovarian Cancer Patients:
Paclitaxel (80mg/m2) IV Day 1, 8, 15 every 28 days, x6 cycles
Pegylated Liposomal Doxorubicin (PLD) (40mg/m2) IV every 28 days, x6 cycles
Topotecan (4mg/m2) IV Day 1, 8, 15 every 28 days, x6 cycles
•
Endometrial Cancer Patients:
Carboplatin (AUC 5) and Paclitaxel (175mg/m2) IV every 21 days, x6 cycles
Doxorubicin IV (60mg/m2) every 21 days x6 cycles
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Nintedanib Dose Delays
•
Treatment with Nintedanib has to be interrupted if any of the criteria listed below are fulfilled:
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Nintedanib Dose Reductions
•
After interruption of Nintedanib the following criteria must be met to restart Nintedanib:
•
GI adverse events:
•
Liver enzyme elevations: -bilirubin values CTCAE grade 0
-AST and ALT CTCAE grade ≤1
•
Neuropathy:
•
Other non-haematological adverse events:
-other non-haematological adverse which are considered drug-related have recovered to less
than or equal to the patient's pre-therapy value at trial enrolment
•
Nintedanib - Dose Modification for Toxicity
-nausea CTCAE grade ≤1
-vomiting CTCAE grade 0
-diarrhoea CTCAE grade ≤1
-neuropathy CTCAE grade ≤2
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Nintedanib Compliance
• Empty Nintedanib bottles and any remaining medication to be returned at
each patient visit
• Pharmacy to perform tablet count (information on handling in IMP
manual)
• Sites will need to have a local process where pharmacy and research staff
review patient returns in a timely manner in order to assess patient
compliance
• Over or under compliance should be escalated to the trial team
• Patients will be provided with a Nintedanib Diary Card to record their
compliance
• Patients given an alert card to carry for duration of clinical trial
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Detailed information on control arm dosing
• Protocol lists criteria for:
– initiation and retreatment - should be assessed for all
chemotherapy regimens for each cycle.
– regimen specific information
– dose modification for toxicity
– dose delays
– dose limiting toxicity
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IMP PRESENTATION AND MANAGEMENT
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Investigational Medicinal Products - Summary
• Provided by sponsor
– Nintendanib
– Store at 15-30oC
• Provided free of charge
• Shipped from Almac
• Full accountability required using
– NiCCC IMP Stock Control
Application and
– NiCCC Master Site
Accountability Log
• Hospital own stock
–
–
–
–
–
Paclitaxel
Pegylated liposomal doxorubicin
Topotecan
Carboplatin
Doxorubicin
• Accountability for traceability
purposes
– Use NiCCC Control Arm
Accountability log
– Retain aseptic worksheets
– Dose banding permitted
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
Prescribing Arrangements
• Study specific prescriptions must be used
• Sites to develop own prescription. Must include following
minimum details in addition to standard prescribing
information:
– clearly identified as NiCCC study. Include Protocol No: /EudraCT No
– NiCCC Subject No
• Electronic prescriptions can be used
• Prescriptions must be version controlled or subject to
validation process
• Copy of final prescription and any updated versions should be
retained in the pharmacy file and a copy sent to investigator
for insertion into investigator site file.
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Presentation of Nintedanib (BIBF1120) supplies
• Open label
– 100mg x 30 capsules
• Multilanguage booklet label
– 150mg x 30 capsules
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Nintedanib orders and distribution
• Initial supply is sent automatically to site only when the first patient
at site is registered to enter the pre-pathology screen.
• Pharmacy sites are responsible thereafter for ensuring that sufficient
supplies of nintedanib held at site
• Replacement supplies must be manually ordered using the NiCCC
Resupply Drug Order Form
• Shipped in validated shippers with elpro temperature data logger
from Almac
• Follow the instructions on the Elpro monitor instruction sheet. PDF
files for all shipments must be sent to the BI Elpro Libero Manager
Database.
• Automated response from the BI Elpro Libero Manager Database.
Please print and retain in pharmacy site file.
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Nintedanib receipt
• If Elpro data logger has alarmed on arrival, quarantine the
shipment at correct storage conditions and e-mail to
IIS@almacgroup.com and R&DIMP@ggc.scot.nhs.uk as per
instructions in IMP manual. Await written response.
• If Elpro data logger arrives without an alarm, nintedanib
supplies can be used and should be receipted on to the NICCC
Master Site Accountability Log and receipted on to the NiCCC
IMP Stock Control application.
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Nintedanib dispensing & accountability (1)
• Individual packs are not allocated, therefore any Med No of
correct strength can be used for any patient. However:
– use lowest available Med No of correct strength first to aid stock
rotation
– Add investigator and patient ID
– Additional dispensing labels may be added as per local practice
provided that pre-printed text is not obscured.
• Accountability is via NICCC IMP stock control application and
NICC Master Site Accountability Log
• Handling information in IMP manual and MSDS available
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Nintedanib dispensing & accountability (2)
Dose
level
Dose
0
200mg
twice
daily
-1*
150mg
twice
daily*
-2*
100mg
twice
daily*
Patient
dosing
information
Take TWO
100mg
capsules
twice daily
Take ONE
150mg
capsule
twice daily
Take ONE
100mg
capsule
twice daily
Supply duration cycles
1-6
Anticipated
Quantity
no. of
to be
capsules to
dispensed
be
returned
4 x 30
Nintedanib
8 x 100mg
100mg
capsules
2 x 30
Nintedanib
4 x 150mg
150mg
capsules
2 x 30
Nintedanib
4 x 100mg
100mg
capsules
Supply duration cycle 7
onwards
Anticipated
Quantity
no. of
to be
tablets to
dispensed
be
returned
8 x 30
Nintedanib
16 x 100mg
100mg
capsules
4 x 30
Nintedanib
8 x 150mg
150mg
capsules
4 x 30
Nintedanib
8 x 100mg
100mg
capsules
NiCCC – Pharmacy Site Initiation Slides v1.0, 25 Jul 2014
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Nintedanib patient returns & destruction
• Sites should have local processes in place to ensure that any
potential patient medication compliance issues can be
addressed by the local PI or delegate in a timely manner.
• Sites are permitted to destroy an patient returned study
medication once returns documented on the IMP stock
control application provided that any discrepancies are
resolved.
• Unused or expired medication can only be destroyed after
written permission has been obtained from CR-UK CTU.
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Control IMPs dispensing & accountability
• Can use dose banded products – see IMP Management and
Accountability Manual for requirements
• Retain aseptic worksheets
• Accountability for traceability purposes recorded on NiCCC
Control Arm IMP Accountability Log
• Add following text in addition to standard dispensing label:
Protocol: NiCCC2013
EudraCT No: 2013-002109-73
Principal Investigator: XXXXXXXX
Subject no: XXXXXXXX
Sponsor: NHS Greater Glasgow and Clyde
For clinical trial use only
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Defects and Temperature Deviations
• Nintedanib
– Quarantine stock under appropriate temperature conditions ie. 1530oC
– Quarantine stock on NiCCC IMP stock control application
– Complete the NiCCC IMP Temperature Deviation and Defect Report
form providing as much detail as possible and e-mail to CTC
– Include temperature log (temperature excursion) or picture (defect).
– Telephone if urgent.
• Control IMPs
– Temperature deviations, product complaints or recall should be
managed as per local site operating procedures
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NICCC STOCK CONTROL APPLICATION
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IMP Stock Control Application (1)
• Simple, intuitive system to record receipt, dispensing, and
destruction.
• System does not automatically trigger replacement
shipments and cannot be used or order replacement supplies.
• Self-directed training using current User Guide and demo site.
Information is provided in Appendix 1 of IMP Management &
Accountability Manual.
• Once training completed, ensure that documented on NiCCC
Pharmacy Site Training Log and return a copy to CTC.
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IMP Stock Control Application (2)
• **LIVE** NiCCC IMP stock control application
accessed via http://www.crukctuglasgow.org
• Support: Please e-mail in the first instance to report any
NiCCC IMP Stock control application problems.
E-mail: mvls-it-ctu@glasgow.ac.uk
Tel: +44 (0) 141 301 720
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PHARMACY SITE INITIATION PROCESS
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Pharmacy Initiation Process
•
•
•
•
•
Site initiation process - Each member of study team is required to participate in
site initiation to ensure compliance with the protocol and training on study
procedures. Initiation will be done by site staff accessing on line initiation slides
via CR-UK CTU website
Lead pharmacist for the NiCCC will complete Pharmacy Site Assessment Form and
return to CR-UK CTU
A Staff Contact and Responsibilities Sheet must be completed for the lead
pharmacist and any other pharmacy clinical trial staff who are delegated IMP
management responsibilities. These staff will be required to provided evidence of
GCP training and current CV’s
Acknowledgement sheet must be completed for each member of the study who
has viewed the initiation slide presentation to confirm completion.
Initiation Accreditation call - Prior to activation of the site a short initiation call
will be completed with the main contact for the site.
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Site Set Up
CTU GLASGOW
Main REC approval - MHRA approval - Site Initiation Slides
- Investigator File - Pharmacy File

SITE
Delegation Log – SSI - R&D Approval
- CVs and GCP certificates for PI and Lead Pharmacist - Clinical Trial Agreement - PIS,
Consent, GP Letter etc on Trust Headed paper
- Lab normal ranges (Haem + Biochem), Accreditation certificates.

INITIATION PROCESS

SITE ACTIVATED

Automatic NINTEDANIB shipment triggered by sponsor when 1st
patient at site enters pre-pathology screen
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POST SITE ACTIVATION & MONITORING
ARRANGEMENTS
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NiCCC – MONITORING UK SITES
Central Monitoring
• trial sites will be monitored centrally by checking incoming forms for compliance with the
protocol, data consistency, missing data and timing. trial staff will be in regular contact with
site personnel (by phone/fax/email/letter) to check on progress and deal with any queries
that they may have.
On-site and Remote Telephone Monitoring
•
The 1st visit will take the form of a remote telephone monitoring visit when the first patient
at site has completed two cycles of treatment
•
A 2nd telephone monitoring visit will be conducted six months after the randomisation of the
1st patient at site
•
The 3rd visit will take the form of an on site monitoring visit 12 months after randomisation
of the first patient at a site. The pharmacy department responsible for the trial will be visited
to allow monitoring of the pharmacy site file and review of security, storage and
accountability of trial drugs.
•
All findings will be discussed at an end of visit and any unresolved issues raised as Action
Points.
•
Action Points will be followed up by the monitor until resolved.
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Once site activated
Site responsibilities
• Ensure Pharmacy site file kept up to date
• Maintain sufficient quantities of nintedanib 100mg and 150mg packs at site
• Ensure NiCCC IMP Stock Control application and accountability logs are kept up to date
• Inform CR-UK CTU Glasgow of any changes in contacts or arrangements for pharmacy
• Action amendments where required.
Sponsor responsibilities
•
•
•
•
Forward amendments in a timely manner
Review and amend IMP management process as required
Help solve problems & provide support as required.
Action Points will be followed up by the monitor until resolved.
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CONTACT DETAILS FOR CRUK CTU
Project Manager
Claire Lawless
Tel: 0141 301 7947
Fax: 0141 301 7946
E-mail: claire.lawless@glasgow.ac.uk
Clinical Trial Coordinator
Laura Douglas
Tel: 0141 301 7215
Fax: 0141 301 7219
E-mail: laura.douglas@glasgow.ac.uk
Pharmacovigilance Manager
Lindsey Connery
Tel:
0141 301 7209
Fax:
0141 301 7213
E-mail: lindsey.connery@glasgow.ac.uk
Pharmacovigilance CTC
Susannah Radford
Tel: 0141 301 7211
Fax: 0141 301 7213
E-mail: susannah.radford@glasgow.ac.uk
Clinical Trial Monitor
Calum Innes
Tel: 0141 301 7948
Fax: 0141 301 7187
Mobile : 07825 030 429
E-mail: calum.innes@glasgow.ac.uk
Postal Address
Cancer Research UK Clinical Trials Unit
Level 0,
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow, G12 0YN
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