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Trial registered on ANZCTR


Registration number
ACTRN12613000991718
Ethics application status
Not yet submitted
Date submitted
27/08/2013
Date registered
5/09/2013
Date last updated
20/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of SUN-101 in Pancreatic Cancer
Scientific title
A Phase 1a/1b Study of SUN-101 in Subjects with Pancreatic Ductal Adenocarcinoma Previously Treated with Gemcitabine or FOLFIRINOX
Secondary ID [1] 283077 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 289915 0
Condition category
Condition code
Cancer 290283 290283 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SUN-101
During the 1a phase of the study, subjects will be enrolled in each of 3 cohorts sequentially:
1) cohort 1: SUN-101, 1.0 mg/kg subcutaneous, 3 subjects
2) cohort 2: SUN-101, 1.5 mg/kg subcutaneous, 3 subjects
3) cohort 3: SUN-101, 2.0 mg/kg subcutaneous, 3 subjects
All cohorts will receive subcutaneous injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks (2 weeks on, 2 weeks off is equal to 1 cycle). A total of (up to) 30 injections, or 3 planned full cycles (total of 12 weeks) will be administered in the absence of disease progression or unacceptable toxicity. In the event of a complete response according to the Response Evaluation Criteria in Solid Tumours (RECIST), one additional cycle will be administered. In the event of a RECIST stable disease or a partial response, subjects will continue to receive SUN-101 up to a total 5 cycles (up to 20 additional doses for a maximum total of 50 doses) of treatment until complete response, disease progression or unacceptable toxicity.
An additional 24 evaluable subjects will be enrolled at the maximum tolerated dose identified in 1a to evaluate the efficacy and safety of SUN-101 at this recommended dose. Subjects in the phase 1b expansion study will receive SUN-101 subcutaneously on Monday through Friday for 2 weeks (10 doses per cycle) at the maximum tolerated dose (MTD) confirmed in Part 1a of this trial, repeated every 4 weeks (2 weeks on, 2 weeks off) for 3 cycles, and up to 5 cycles with partial response or stable disease, or until disease progression or unacceptable toxicity. If a dose is missed during the two weeks of dosing, it should be made up during the third week.
Intervention code [1] 287793 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290337 0
The primary objective of the phase 1a First-in-Human study is to determine the maximum tolerated dose and dose limiting toxicities (DLT) of SUN-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. This will be done by monitoring each participant for study drug treatment-related toxicities at each dose level.
Timepoint [1] 290337 0
After Phase 1a completed
Primary outcome [2] 290338 0
The primary objective of the phase 1b expansion study is to further establish the safety and tolerability of the SUN-101 at the MTD and to explore efficacy endpoints. This will be done by monitoring safety (number and severity of adverse events, laboratory results, vital signs, changes in bowel habits) and tumour assessment (CT scan) and tumour biomarker CA19-9.
Timepoint [2] 290338 0
After 24 subjects completed Phase 1b
Secondary outcome [1] 304325 0
To describe the toxicities of SUN-101 in this setting as defined by using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE)
Timepoint [1] 304325 0
After all subjects completed 3- 5 cycles of treatment
Secondary outcome [2] 304326 0
To describe the pharmacokinetics of SUN-101.
This will be done by collecting a number of blood and urine samples from participants.
Phase 1a- 11 blood samples taken at Cycle 1 Day 1 and Day 11 (before study drug dose and every 30 minutes up to 4 hours, 8 hours, 12 hours and 24 hours after study drug dose) and one blood sample taken before the first dose at Cycles 2, 3 and 4. One urine sample collected before study drug dose at Cycle 1 day 1 and a 24 hour urine collection collected at Cycle 1 day 12.
Phase 1b- One sample taken before study drug dose at Cycle 1 day 1 and day 12 and 1 hour after dose on Cycle 1 day 12.
Timepoint [2] 304326 0
After all subjects completed 3- 5 cycles of treatment
Secondary outcome [3] 304327 0
To document any antitumor activity in subjects treated with SUN-101. This will be assessed by CT scan and by tumour marker CA19-9.
Timepoint [3] 304327 0
After all subjects completed 3- 5 cycles of treatment

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed metastatic or locally advanced ductal adenocarcinoma of the pancreas with CT scan measurable disease by RECIST criteria.
2. ECOG Performance Status 0 or 1
3. Received one, and only one, line of systemic therapy for their pancreatic locally advanced or metastatic pancreatic adenocarcinoma, including either: gemcitabine (with or without Abraxane, or another agent) or FOLFIRINOX or prior investigator-modified FOLFIRINOX regimen.
4. Adult, age greater than or equal to 18, male or female
5. Females of child-bearing potential must use investigator-approved method of contraception. All sexually active males must also use an investigator approved method of contraception.
6. Adequate bone marrow, hepatic, renal and coagulation function:
7. Adequate renal function, with calculated creatinine clearance greater than 50 mL/min using the Cockcroft and Gault equation
8. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol
2. Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
3. Presence of islet-cell or pancreatic neuroendocrine tumour or mixed adenocarcinoma-neuroendocrine carcinoma
4. Have symptomatic central nervous system (CNS) malignancy or metastasis.
5. Serum albumin levels less than 30 g/L
6. Life expectancy less than 12 weeks
7. Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
8. Known infection with HIV, hepatitis B or C
9. Presence of congestive heart failure or symptomatic coronary artery disease, interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction
10. Lack of physical integrity of the upper gastrointestinal tract
11. Malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.
12. Known, existing coagulopathy or receiving anticoagulants
13. Pregnant or lactating
14. Major surgery within 4 weeks of the start of study treatment, without complete recovery
15. Participation in any other clinical investigation within 4 weeks of enrolment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Data analyses will be provided by dose groups and for all study subjects combined wherever appropriate. For continuous variables, summary statistics will include number of subjects, mean, median, standard deviation, minimum, and maximum. Categorical endpoints will be summarized using number of subjects, frequency, and percentages.

Safety analyses will be conducted for all enrolled subjects who receive at least 1 dose of study drug, whether or not they complete all protocol requirements. Safety parameters will be listed and summarized using standard descriptive statistics. Adverse event terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized by dose. Incidence of adverse events occurring during the study will be summarized by system organ class (SOC) and preferred term. Adverse events will also be summarized by causality and grade. Serious adverse events will be listed separately. The rate of DLTs per dose level will be presented. All DLTs will be presented in data listings. Descriptive summary statistics will be used to summarize changes in laboratory values and vital signs by dose. Additional analyses will be performed if warranted upon review of the data.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2013
Actual
Date of last participant enrolment
Anticipated
30/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 287847 0
Commercial sector/Industry
Name [1] 287847 0
Sun BioPharma Australia Pty Ltd
Country [1] 287847 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sun BioPharma Australia Pty Ltd
Address
Level 27 150 Lonsdale Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 286577 0
None
Name [1] 286577 0
Address [1] 286577 0
Country [1] 286577 0
Other collaborator category [1] 277589 0
Commercial sector/Industry
Name [1] 277589 0
Novotech (Australia) Pty Ltd
Address [1] 277589 0
Level 3, 235 Pyrmont St
Pyrmont NSW 2009
Country [1] 277589 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289789 0
Peter MacCallum Human Research Ethics Committee
Ethics committee address [1] 289789 0
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 289789 0
Australia
Date submitted for ethics approval [1] 289789 0
06/09/2013
Approval date [1] 289789 0
Ethics approval number [1] 289789 0

Summary
Brief summary
The main goal of this study is to assess the safety and tolerability of the drug, SUN-101, in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic or locally advanced ductal adenocarcinoma of the pancreas, which has been previously treated with first line chemotherapy. Study details: Participants in the first part of this study (Phase 1a) will be administered SUN-101 in a dose-escalation scheme with cohorts of three patients at each dose level (1.0, 1.5 and 2.0 mg/kg). All cohorts will receive injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks for up to 5 full cycles (up to 50 injections) depending on response. Participants in the second part of this study (Phase 1b) will be administered SUN-101 at the maximum tolerated dose identified in Phase 1a for up to 5 cycles. SUN-101 is a small molecule which is similar to a compound found naturally in human cells. Laboratory and animal studies suggest that SUN-101 targets and destroys the ductal cells in the pancreas where the tumour grows. Participants will be regularly assessed during treatment in order to assess safety and tolerability. Other goals of this study are to measure the levels of SUN-101 in the blood and urine over time and test whether SUN-101 can slow the growth of, or shrink tumours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42386 0
A/Prof Michael Michael
Address 42386 0
Peter MacCallum Cancer Centre
Division of Cancer Medicine
Upper GI Oncology Service
St Andrews Place
East Melbourne VIC 3002

Country 42386 0
Australia
Phone 42386 0
+61 3 9656 1159
Fax 42386 0
Email 42386 0
[email protected]
Contact person for public queries
Name 42387 0
Sheri Smith
Address 42387 0
Courante Oncology
202 Water Street, Suite 201, Excelsior, MN, 55331
Country 42387 0
United States of America
Phone 42387 0
+1 952 908 9986
Fax 42387 0
Email 42387 0
[email protected]
Contact person for scientific queries
Name 42388 0
Michael T. Cullen
Address 42388 0
SunBioPharma Australia Pty Ltd
918 Kings Crown Drive
Sanibel, FL 33957-4908
Country 42388 0
United States of America
Phone 42388 0
+1 612 940 6056
Fax 42388 0
Email 42388 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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