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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/NCT03517176




Registration number
NCT03517176
Ethics application status
Date submitted
15/03/2018
Date registered
7/05/2018
Date last updated
27/10/2022

Titles & IDs
Public title
CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
Scientific title
A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer
Secondary ID [1] 0 0
U1111-1213-3234
Secondary ID [2] 0 0
CEND1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CEND-1
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine

Experimental: Part A (Dose Escalation) - Safety of ascending dose levels of CEND-1 in combination with gemcitabine and nab-paclitaxel will be evaluated. Patients will receive an IV bolus of CEND-1 on Day 1 of the 1-week run-in period. This is followed by one treatment cycle (28 days) with the CEND-1 / nab-paclitaxel (125mg/m^2) / gemcitabine (1000mg/m^2) combination given on Days 1, 8, 15.

Experimental: Part B (Expansion) - Safety and early efficacy of CEND-1 in combination with nab-paclitaxel (125mg/m^2) and gemcitabine (1000mg/m^2) will be evaluated (dosing on Days 1, 8, 15 of the 28-day treatment cycle). Treatment cycles will be repeated every 4 weeks based on toxicity and response. Treatment may continue as long as there is perceived benefit or until disease progression.


Treatment: Drugs: CEND-1
CEND-1 will be provided as concentrate for solution to be administered via IV injection.

Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel will be provided as solution to be administered via IV infusion.

Treatment: Drugs: Gemcitabine
Gemcitabine will be provided as solution to be administered via IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safe doses of CEND-1 when given alone or in combination with nabpaclitaxel and gemcitabine
Timepoint [1] 0 0
Escalation Phase: From Day 1 of the run-in until Day 28 of Cycle 1 (cycle length=28 days)
Primary outcome [2] 0 0
Optimal Biological Dose (OBD) of CEND-1 when given in combination
Timepoint [2] 0 0
Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days)
Secondary outcome [1] 0 0
Pharmacokinetics of CEND-1 when given alone or in combination with nabpaclitaxel and gemcitabine
Timepoint [1] 0 0
Escalation phase: Predose, 3 minutes, 15 min, 30 min, 1 h, 4 h, 8 h postdose on Day 1 of the run-in and Day 1 of Cycle 1
Secondary outcome [2] 0 0
Disease Control Rate (Complete Remission (CR) + Partial Remission (PR) + Stable Disease (SD)) associated with the administration of CEND-1 in combination with nabpaclitaxel and gemcitabine
Timepoint [2] 0 0
Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days)
Secondary outcome [3] 0 0
Preliminary evidence of anti-tumor activity of CEND-1 when given in combination with nabpaclitaxel bound and gemcitabine by objective radiographic assessment according to RECIST 1.1
Timepoint [3] 0 0
Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days)

Eligibility
Key inclusion criteria
- Patients with histologically confirmed metastatic pancreatic ductal carcinoma

- One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan
according to RECIST v1.1.

- Eligible for treatment with nabpaclitaxel and gemcitabine

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 3 months

- Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to
undergo biopsy before treatment starts

- The patient is capable of understanding and complying with the protocol and the
subject or, when applicable, the subject's legally acceptable representative has
signed the informed consent

- A negative serum pregnancy test (if a premenopausal female patient)

- Acceptable liver function: Bilirubin = 1.5 times upper limit of normal; AST (SGOT) <
10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper
limit of normal (if liver metastases are present, then = 5 x ULN is allowed).

- Acceptable renal function: Serum creatinine within normal limits; calculated
creatinine clearance = 60 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal by the Cockroft-Gault equation.

- Acceptable hematologic status: Granulocyte = 1500 cells/mm3; Platelet count = 100,000
plt/mm3; Hemoglobin = 9 g/dL.

- Urinalysis: No clinically significant abnormalities.

- Acceptable coagulation status: PT within normal limits; PTT within normal limits.

- For men and women of child-producing potential, the use of effective contraceptive
methods during the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior chemotherapy or any other investigational agents for the treatment of pancreatic
cancer.

- Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted
therapy, immunotherapy, or biological agents.

- Participants with known brain metastases.

- New York Heart Association Class III or IV, cardiac disease, myocardial infarction
within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy.

- Pregnant or nursing women. Women of child-bearing potential and men must agree to use
adequate contraception.

- Unwillingness or inability to comply with procedures required in this protocol.

- Known infection with HIV, hepatitis B, or hepatitis C.

- Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions
per physician judgement) that could compromise protocol objectives in the opinion of
the investigator and/or the sponsor.

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
Other
Other design features
Phase
Phase 1
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
31/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2020
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lisata Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CEND-1, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma
Trial website
https://clinicaltrials.gov/ct2/show/NCT03517176
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/NCT03517176