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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02993731




Registration number
NCT02993731
Ethics application status
Date submitted
13/12/2016
Date registered
15/12/2016
Date last updated
15/11/2023

Titles & IDs
Public title
A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Scientific title
A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
CanStem111P
Universal Trial Number (UTN)
Trial acronym
CanStem111P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Pancreatic Ductal 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Napabucasin
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine

Experimental: Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine - Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.

Active Comparator: Arm 2: Nab-paclitaxel with Gemcitabine - Patients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.


Treatment: Drugs: Napabucasin
Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.

Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Treatment: Drugs: Gemcitabine
Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Secondary outcome [2] 0 0
Disease Control Rate
Timepoint [2] 0 0
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Secondary outcome [3] 0 0
Overall Response Rate
Timepoint [3] 0 0
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Secondary outcome [4] 0 0
Number of Patients With Adverse Events
Timepoint [4] 0 0
Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
Secondary outcome [5] 0 0
Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
Timepoint [5] 0 0
8 weeks

Eligibility
Key inclusion criteria
1. Written, signed consent for trial participation must be obtained from the patient
appropriately in accordance with applicable International Conference on Harmonization
(ICH) guidelines and local and regulatory requirements prior to the performance of any
study specific procedure.

2. Must have histologically or cytologically confirmed advanced pancreatic ductal
adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC
will be made by integrating the histopathological data within the context of the
clinical and radiographic data. Patients with islet cell neoplasms are excluded.

3. Must not have previously received chemotherapy or any investigational agent for the
treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation
sensitizer in the adjuvant setting is allowed for as long as last dose was
administered > 6 months prior to randomization and no lingering toxicities are
present.

4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended
by the Investigator.

5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI,
if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations
including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all
sites of disease must be performed within 14 days prior to randomization. Qualifying
scans performed as part of standard of care prior to patient signature of the study
informed consent will be acceptable as baseline scanning as long as scanning is
performed < 14 days prior to randomization.

6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1,
assessed within 14 days prior to randomization. Two observers qualified to perform
assessment of the performance status will be required to perform this assessment. If
discrepant, the one with the most deteriorated performance status will be considered
true.

7. Must have life-expectancy of > 12 weeks.

8. Must be = 18 years of age. Due to increased risk of sepsis in patients >80 years old,
candidate patients in this age group should be thoroughly evaluated prior to study
randomization to ensure they are fit to receive chemotherapy. In addition to all of
the inclusion/exclusion criteria listed, clinical judgment should be used regarding
patients' susceptibility to infection (including but not limited to presence of
ascites or diabetes mellitus increasing risk of infection). Furthermore, the expected
stability of their performance status while receiving repeat weekly chemotherapy
cycles should be given special attention. Patients in this age group should not be
randomized on the study should there be any hesitation on any of these considerations.

9. For male or female patients of child producing potential: Must agree to use
contraception or take measures to avoid pregnancy during the study and for 180 days
after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female
patients and for 90 days for male patients, after the final napabucasin dose if
nab-paclitaxel and gemcitabine were not administered.

10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 5 days prior to randomization.

11. Patient has adequate biological parameters as demonstrated by the following blood
counts at baseline (obtained < 14 days prior to randomization; laboratory testing
performed as part of standard of care prior to patient signature of informed consent
for the study will be acceptable as baseline laboratory work as long as testing is
performed < 14 days prior to randomization):

1. Absolute neutrophil count (ANC) > 1.5 x 10^9/L

2. Platelet count > 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion
of platelets within 1 week of baseline platelet count assessment.

3. Hemoglobin (HgB) > 9 g/dL. Must not have required transfusion of red blood cells
within 1 week of baseline Hgb assessment.

12. Patient has the following blood chemistry levels at baseline (obtained < 14 days prior
to randomization; laboratory testing performed as part of standard of care prior to
patient signature of informed consent for the study will be acceptable as baseline
laboratory work as long as testing is performed < 14 days prior to randomization):

1. AST (SGOT) and ALT (SGPT) = 2.5 × institutional upper limit of normal (ULN) [= 5
× ULN in presence of liver metastases]

2. Total bilirubin = 1.5 x institutional ULN. If total bilirubin is > ULN and < 1.5
x ULN, it must be non-rising for at least 7 days.

3. Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73
m^2 for patients with serum creatinine levels above or below the institutional
normal value. If using creatinine clearance, actual body weight should be used
for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For
patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be
used instead.

13. Patient not on anticoagulation has acceptable coagulation studies (obtained < 14 days
prior to randomization; laboratory testing performed as part of standard of care prior
to patient signature of informed consent for the study will be acceptable as baseline
laboratory work as long as testing is performed < 14 days prior to randomization) as
demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or
within normal limits (+15%).

Patients on anticoagulation must have coagulation values within the therapeutic range
appropriate for the anti-coagulation indication.

14. Patient has no clinically significant abnormalities on urinalysis results (obtained <
14 days prior to randomization; laboratory testing performed as part of standard of
care prior to patient signature of informed consent for the study will be acceptable
as baseline laboratory work as long as testing is performed < 14 days prior to
randomization).

15. Patient must have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m^2
and body weight of > 40 kg with serum albumin > 3 g/dL.

16. Baseline laboratory evaluations must be done within 14 days prior to randomization and
some must be repeated < 72 hours prior to randomization.

17. Patients requiring biliary stent placement must have biliary stent placed > 7 days
prior to screening.

18. Pain symptoms should be stable (of tolerable Grade 2 or less).

19. Only patients with available archival tumor tissue must consent to provision of, and
Investigator(s) must confirm access to and agree to submit a representative formalin
fixed paraffin block of tumor tissue in order that the specific correlative marker
assays (Correlative Studies) of this protocol may be conducted. Submission of the
tissue does not have to occur prior to randomization. Where local center regulations
prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block
and 5-20 unstained slides of whole sections of representative tumor tissue are
preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block,
5-20 unstained slides of representative tumor tissue are also acceptable. Where no
previously resected or biopsied tumor tissue exists or is available, on the approval
of the Sponsor/designated CRO, the patient may still be considered eligible for the
study.

20. Patient must consent to provision of a sample of blood in order that the specific
correlative marker assays (Correlative Studies) may be conducted.

21. Patients must be accessible for treatment and follow up. Patients registered on this
trial must receive protocol treatment and be followed at the participating center.
This implies there must be reasonable geographical limits placed on patients being
considered for this trial. Investigators must ensure that the patients randomized on
this trial will be available for complete documentation of the treatment, response
assessment, adverse events, and follow-up.

22. Protocol treatment is to begin within 2 calendar days of patient randomization for
patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol
treatment within 7 calendar days of randomization.

23. The patient is not receiving therapy in a concurrent clinical study and the patient
agrees not to participate in other interventional clinical studies during their
participation in this trial while on study treatment. Patients participating in
surveys or observational studies are eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with no evidence of metastatic disease as well as patients with a local
recurrence following surgical resection of primary lesion.

2. Patient has experienced a decline in ECOG performance status between Baseline visit
and within 72 hours prior to randomization.

3. Patient has a > 20% decrease in serum albumin level between Baseline visit and within
72 hours prior to randomization.

4. Patient has a > 10% decrease in weight between Baseline visit and within 72 hours
prior to randomization.

5. Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.

1. Patients receiving immunotherapy for non-cancer related treatment within < 4
weeks of first planned dose of study treatment will be excluded.

2. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the
adjuvant setting is allowed for as long as last dose was administered > 6 months
prior to randomization.

6. Major surgery within 4 weeks prior to randomization.

7. Any known brain or leptomeningeal metastases are excluded, even if treated.

8. Patients with clinically significant ascites or pleural effusions.

9. Women who are pregnant or breastfeeding. Women should not breastfeed while taking
study treatment and for 4 weeks after the last dose of napabucasin or while undergoing
treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of
nab-paclitaxel and gemcitabine.

10. Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator,
would significantly impede the absorption of an oral agent (e.g. active Crohn's
disease, ulcerative colitis, extensive gastric and small intestine resection).

11. Unable or unwilling to swallow napabucasin capsules daily.

12. Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, clinically significant non-healing or healing wounds, symptomatic
congestive heart failure, unstable angina pectoris, clinically significant cardiac
arrhythmia, significant pulmonary disease (shortness of breath at rest or mild
exertion), uncontrolled infection or psychiatric illness/social situations that would
limit compliance with study requirements.

1. History of cardiac disease: congestive heart failure (CHF) > New York Heart
Association (NYHA) Class II; active coronary artery disease, myocardial
infarction or coronary stenting within 6 months prior to randomization;
unevaluated new onset angina within 3 months or unstable angina (angina symptoms
at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers
or digoxin are permitted).

2. Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or
diastolic pressure > 90 mmHg despite optimal medical management) as well as prior
history of hypertensive crisis or hypertensive encephalopathy.

3. Significant vascular disease (e.g., aortic aneurysm, aortic dissection,
symptomatic peripheral vascular disease including claudication, Leo Buerger's
disease). Treated peripheral vascular disease that is stable for at least 6
months is allowed.

4. Evidence of bleeding diathesis or clinically significant coagulopathy.

5. Major surgical procedure (including open biopsy, significant traumatic injury,
etc.) within 28 days, or anticipation of the need for major surgical procedure
during the course of the study as well as minor surgical procedure (excluding
placement of a vascular access device or bone marrow biopsy) within 7 days prior
to randomization.

6. Patients with clinically significant abnormalities on urinalysis at < 14 days
prior to randomization.

7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to randomization.

8. Ongoing serious, non-healing wound, ulcer, or bone fracture.

9. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection
with hepatitis B, or hepatitis C.

10. History of interstitial lung disease, history of slowly progressive dyspnea and
unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,
pulmonary hypersensitivity pneumonitis or multiple allergies.

11. History of hemolytic-uremic syndrome.

12. History of connective tissue disorders (eg, lupus, scleroderma, arteritis
nodosa).

13. Serious medical risk factors involving any of the major organ systems, or serious
psychiatric disorders that could compromise the patient's safety or the study
data integrity.

13. Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the
patient exhibits any of the events outlined in the Contraindications or Special
Warnings and Precautions sections of the product or comparator Summary of Product
Characteristics or Prescribing Information. Possible hypersensitivity to napabucasin
or one of the excipients which include the azo dyes sunset yellow and allura red.

14. Neurosensory neuropathy > grade 2 at baseline.

15. Uncontrolled chronic diarrhea > grade 2 at baseline.

16. Patients being treated with Warfarin.

17. Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring
systemic therapy

18. Patients with a history of other malignancies except: adequately treated non-melanoma
skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors
curatively treated by surgery alone or surgery plus radiotherapy with no evidence of
disease continuously for > 5 years.

19. Any active disease condition which would render the protocol treatment dangerous or
impair the ability of the patient to receive protocol therapy.

20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance
with the protocol, including patients with history of poor compliance or history of
drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere
with the ability to comply with the study protocol. Patients planning to take a
vacation for 14 or more consecutive days during the course of the study are
ineligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2020
Sample size
Target
Accrual to date
Final
1134
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
ICON Cancer Care - South Brisbane
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [5] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [6] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [8] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [9] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [10] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
2109 - East Albury
Recruitment postcode(s) [2] 0 0
2109 - Sydney
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4101 - South Brisbane
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3144 - Malvern
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2148 - Blacktown
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2640 - East Albury
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3084 - Heidelberg
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6009 - Nedlands
Recruitment postcode(s) [9] 0 0
2031 - Randwick
Recruitment postcode(s) [10] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [11] 0 0
2076 - Wahroonga
Recruitment outside Australia
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Czechia
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Amberg
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Bonn
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Chemnitz
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Hannover
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Heilbronn
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Mannheim
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München
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Oldenburg
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Brescia
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Candiolo
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Italy
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Catanzaro
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Faenza
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Feltre
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Meldola
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Milano
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Perugia
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Reggio Emilia
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Rimini
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Torino
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Varese
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Aichi
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Ehime
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Hokkaido
Country [112] 0 0
Japan
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Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sumitomo Pharma America, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly
nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult
patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02993731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02993731