Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12620001317987
Ethics application status
Approved
Date submitted
3/11/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to assess if pantoprazole affects the absorption of capecitabine in patients with breast and gastrointestinal cancers.
Query!
Scientific title
Does the Concomitant Administration of Proton Pump Inhibitors Effect Capecitabine Pharmacokinetics? – A Prospective, Single-Centre, Two-Arm, Randomised, Unblinded, Cross-Over Bioequivalence Study of Capecitabine With or Without Concomitant Pantoprazole.
Query!
Secondary ID [1]
302680
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
APEC
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
319600
0
Query!
Gastrointestinal Cancer
319601
0
Query!
colorectal cancer
319933
0
Query!
Condition category
Condition code
Cancer
317540
317540
0
0
Query!
Breast
Query!
Cancer
317541
317541
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Cancer
317871
317871
0
0
Query!
Bowel - Small bowel (duodenum and ileum)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Consented participants who are scheduled for capecitabine monotherapy for breast or gastrointestinal cancer will be randomly allocated to receive concomitant oral pantoprazole 40mg daily, 4 days prior to and on the first day (total 5 doses) of either the first (group A) or second (Group B) cycle of capecitabine. Pharmacokinetic blood and urine sampling for capecitabine will be performed over eight hours on both cycle1 day 1 and cycle 2 day 1 to determine if PK parameters are different with pantoprazole. Participants will be contacted by phone a day before their course of pantoprazole begins and will receive a daily text reminder on the subsequent 4 days. A medication diary will be kept. The washout period is 21 days (in between cycle 1 day 1 and cycle 2 day 1)
Query!
Intervention code [1]
318965
0
Treatment: Drugs
Query!
Comparator / control treatment
This is a cross-over study. Each patient will serve as their own control. The control is capecitabine monotherapy WITHOUT pantoprazole 4 days before and on the first day of a capecitabine cycle
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
325583
0
Area Under the Curve AUC(0-8) of 5”DFUR (Blood and urine sample)
Query!
Assessment method [1]
325583
0
Query!
Timepoint [1]
325583
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Primary outcome [2]
325584
0
Area Under the Curve AUC(0-8) of 5-FU (blood and urine sample)
Query!
Assessment method [2]
325584
0
Query!
Timepoint [2]
325584
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [1]
388452
0
AUC(0-8) of Capecitabine (blood and urine)
Query!
Assessment method [1]
388452
0
Query!
Timepoint [1]
388452
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [2]
388453
0
Time to maximum concentration (Tmax) of capecitabine. (Blood test)
Query!
Assessment method [2]
388453
0
Query!
Timepoint [2]
388453
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [3]
388454
0
Maximum concentration (Cmax) of capecitabine (blood test)
Query!
Assessment method [3]
388454
0
Query!
Timepoint [3]
388454
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [4]
389435
0
AUC(0-8) of 5'DFCR (blood and urine)
Query!
Assessment method [4]
389435
0
Query!
Timepoint [4]
389435
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [5]
389436
0
AUC(0-8) of FBAL (blood and urine)
Query!
Assessment method [5]
389436
0
Query!
Timepoint [5]
389436
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [6]
389437
0
Time to maximum concentration (Tmax) of 5'DFCR. (Blood test)
Query!
Assessment method [6]
389437
0
Query!
Timepoint [6]
389437
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [7]
389438
0
Time to maximum concentration (Tmax) of FBAL (Blood test)
Query!
Assessment method [7]
389438
0
Query!
Timepoint [7]
389438
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [8]
389439
0
Time to maximum concentration (Tmax) of 5FU. (Blood test)
Query!
Assessment method [8]
389439
0
Query!
Timepoint [8]
389439
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [9]
389440
0
Time to maximum concentration (Tmax) of 5'DFUR. (Blood test)
Query!
Assessment method [9]
389440
0
Query!
Timepoint [9]
389440
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [10]
389441
0
Maximum concentration (Cmax) of 5FU (blood test)
Query!
Assessment method [10]
389441
0
Query!
Timepoint [10]
389441
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [11]
389442
0
Maximum concentration (Cmax) of 5'DFCR (blood test)
Query!
Assessment method [11]
389442
0
Query!
Timepoint [11]
389442
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [12]
389443
0
Maximum concentration (Cmax) of 5'DFUR (blood test)
Query!
Assessment method [12]
389443
0
Query!
Timepoint [12]
389443
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Secondary outcome [13]
389444
0
Maximum concentration (Cmax) of FBAL (blood test)
Query!
Assessment method [13]
389444
0
Query!
Timepoint [13]
389444
0
Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole
Query!
Eligibility
Key inclusion criteria
adults (18+ years) with histologically confirmed GI or breast cancer, receiving adjuvant or palliative capecitabine monotherapy within the Regional Cancer and Blood Services, Auckland District Health Board. Adequate functional status (ECOG 2 or less) and organ function as defined as (i) Neutrophil>1.5, Hb>9g, Platelet>100,000, (ii) Bilirubin<1.5x ULN, ALT, AST <2.0 ULN, (iii) Creatinine clearance calculated by Cockcroft Gault >50ml/min within 14 days of cycle 1.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Previous capecitabine use, recent Proton pump inhibitors (PPI), /H2 Receptor Blocker or antacid use, pre-existing gastritis/ gastro-oesophageal reflux necessitating treatment, previous intolerance to PPI and any condition deemed by study investigators to significantly affect normal gastrointestinal tract function (e.g. upper gastrointestinal tract surgery/ radiation/ pre-existing condition)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (using random lengths 4 / 6)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Bio-equivalence
Query!
Statistical methods / analysis
Statistical approach applied in bioequivalence study will be employed with the use of 90% confidence intervals. The geometric mean and 90%CI of the AUC(0-8) ratios will be estimated and compared to the internationally accepted bio-equivalence margin of 0.80- 1.25. The pharmacokinetic parameters will be considered to not differ after the addition of pantoprazole, if the 90% CI lies entirely within that boundary. The two AUC estimates will be computed for each individual. The estimates will be logged and differences obtained (corresponding to the ratio of the two AUCs). A linear model will be used adjusting for period and treatment order. The adjusted mean difference can be compared to (-0.2231,0.2231) or exponentiated to compare with (0.80, 1.25).
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
7/12/2020
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
7/01/2022
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2022
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
23085
0
New Zealand
Query!
State/province [1]
23085
0
Auckland
Query!
Funding & Sponsors
Funding source category [1]
307119
0
Charities/Societies/Foundations
Query!
Name [1]
307119
0
Gut Cancer Foundation New Zealand
Query!
Address [1]
307119
0
Level 5, Tower One, 205 Queen Street, Auckland CBD, Auckland 1010
Query!
Country [1]
307119
0
New Zealand
Query!
Primary sponsor type
Hospital
Query!
Name
Auckland District Health Board
Query!
Address
Research Office ADHB
Level 14, Support Building, Auckland City Hospital
Private Bag 92024, 1023, Auckland, New Zealand
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
307691
0
None
Query!
Name [1]
307691
0
Query!
Address [1]
307691
0
Query!
Country [1]
307691
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
307231
0
Health and Disability Ethics Committees (HDECs)
Query!
Ethics committee address [1]
307231
0
133 Molesworth Street
Thorndon
Wellington 6011
Query!
Ethics committee country [1]
307231
0
New Zealand
Query!
Date submitted for ethics approval [1]
307231
0
10/11/2020
Query!
Approval date [1]
307231
0
17/11/2020
Query!
Ethics approval number [1]
307231
0
20/NTB/289
Query!
Summary
Brief summary
Proton pump inhibitors (PPIs) are very common medications used for managing gastritis and reflux. Patients on chemotherapy tend to have more problems with gastritis and reflux and approximately 20-55% patients on chemotherapy are reported to be on PPIs. Capecitabine is a tablet form of chemotherapy widely used to treat cancer and has to be absorbed in the gut to be effective. Recent studies have raised concerns that individuals on capecitabine who are also prescribed with PPIs may have poorer cancer survival outcomes compared to those who are not on PPIs. One suggestion is that changes in the pH of the stomach from PPI use, affects the dissolution of the tablet and decreases how much capecitabine enters the body.In late 2019, the NZ regulatory body MEDSAFE advised NZ oncologists that there may be a possible interaction between PPI drugs and capecitabine, but fell short of making any specific recommendations due to the paucity of good quality data.
To address this very real and relevant concern, we plan to conduct a study that will help us determine whether pantoprazole, an approved PPI, affects capecitabine absorption. The study will be conducted in Auckland City Hospital and will involve 20 patients who are scheduled to receive capecitabine for their bowel or breast cancer treatment. The study will span the first 2 cycles (6 weeks) of their capecitabine treatment. Each participant will receive a short course of pantoprazole either before their first or second cycle of capecitabine (cross over design). Whether they receive pantoprazole before the first or second cycle will be randomly assigned (randomization). On the first day of both cycles of capecitabine, blood and urine samples will be collected over an 8 hour period. The samples will be analysed to determine how much capecitabine was absorbed and processed in each participant (pharmacokinetic study). This will allow us to compare if the short course of pantoprazole had any effects on capecitabine.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
106490
0
Dr Edmond Ang
Query!
Address
106490
0
Cancer and Blood Research, Auckland City Hospital
2, Park Road, Grafton,
Auckland 1023
Query!
Country
106490
0
New Zealand
Query!
Phone
106490
0
+64275236584
Query!
Fax
106490
0
Query!
Email
106490
0
[email protected]
Query!
Contact person for public queries
Name
106491
0
Dr Edmond Ang
Query!
Address
106491
0
Cancer and Blood Research, Auckland City Hospital
2, Park Road, Grafton,
Auckland 1023
Query!
Country
106491
0
New Zealand
Query!
Phone
106491
0
+64275236584
Query!
Fax
106491
0
Query!
Email
106491
0
[email protected]
Query!
Contact person for scientific queries
Name
106492
0
Dr Edmond Ang
Query!
Address
106492
0
Cancer and Blood Research, Auckland City Hospital
2, Park Road, Grafton,
Auckland 1023
Query!
Country
106492
0
New Zealand
Query!
Phone
106492
0
+64275236584
Query!
Fax
106492
0
Query!
Email
106492
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Not applicable/ PK study.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF