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History of Changes for Study: NCT03517176
CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
Latest version (submitted October 24, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 3, 2018 None (earliest Version on record)
2 July 23, 2018 Contacts/Locations and Study Status
3 August 1, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 September 11, 2018 Contacts/Locations and Study Status
5 September 18, 2018 Contacts/Locations and Study Status
6 October 15, 2018 Study Status and Contacts/Locations
7 November 13, 2018 Study Status and Contacts/Locations
8 December 26, 2018 Outcome Measures, Study Status, Eligibility and Study Description
9 December 29, 2018 Eligibility and Study Status
10 September 6, 2019 Contacts/Locations and Study Status
11 December 4, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
12 October 24, 2020 Recruitment Status and Study Status
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Study NCT03517176
Submitted Date:  May 3, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: CEND1-001
Brief Title: CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
Official Title: A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer
Secondary IDs: U1111-1213-3234 [The Universal Trial Number (UTN)]
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: June 1, 2018
Primary Completion: October 1, 2019 [Anticipated]
Study Completion: December 30, 2019 [Anticipated]
First Submitted: March 15, 2018
First Submitted that
Met QC Criteria:
May 3, 2018
First Posted: May 7, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 3, 2018
Last Update Posted: May 7, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lisata Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: CEND-1, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma
Detailed Description:

This is an open-label, multicenter, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of CEND-1 in combination with nabpaclitaxel and gemcitabine administered weekly for three weeks followed by one week off over 28 days.

This protocol is designed to evaluate the safety, tolerability, and biologic activity of CEND-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who are undergoing combination therapy with nabpaclitaxel and gemcitabine. CEND-1 is a tumor-penetrating peptide (scientifically also known as iRGD) that activates a drug transport mechanism specifically in tumors.

Study involves an initial dose escalation phase with three different CEND-1 dose levels, first as a monotherapy (during 1-week run-in), followed by combination therapy with nabpaclitaxel and gemcitabine (one 28-day treatment cycle). A subsequent expansion phase with approximately 28 subjects will assess the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels.

Open or close this module Conditions
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 34 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Drug: CEND-1
CEND-1 will be provided as concentrate for solution to be administered via IV injection.
Other Names:
  • iRGD
Drug: Nab-paclitaxel
Nab-paclitaxel will be provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Drug: Gemcitabine
Gemcitabine will be provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
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.
Drug: CEND-1
CEND-1 will be provided as concentrate for solution to be administered via IV injection.
Other Names:
  • iRGD
Drug: Nab-paclitaxel
Nab-paclitaxel will be provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Drug: Gemcitabine
Gemcitabine will be provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safe doses of CEND-1 when given alone or in combination with nabpaclitaxel and gemcitabine
[ Time Frame: Escalation Phase: From Day 1 of the run-in until Day 28 of Cycle 1 (cycle length=28 days) ]

Safety and toxicity profile of treatment regimen as measured by grade and frequency of adverse events, graded and documented according to the NCI CTCAE, version 5.0 guidelines
2. Optimal Biological Dose (OBD) of CEND-1 when given in combination
[ Time Frame: Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days) ]

OBD will be determined by evaluating the tumor marker CA19-9 Response Rate, the ECOG Performance Status and the Disease Control Rate
Secondary Outcome Measures:
1. Pharmacokinetics of CEND-1 when given alone or in combination with nabpaclitaxel and gemcitabine
[ Time Frame: Escalation phase: Predose, 3 minutes, 15 min, 30 min, 1 h, 3 h, 6 h postdose on Day 1 of the run-in and Day 1 of Cycle 1 ]

Area Under the Concentration-Time Curve of CEND-1 Following Intravenous (IV) Administration
2. 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
[ Time Frame: Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days) ]

3. 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
[ Time Frame: Expansion Phase: from baseline until treatment discontinuation and approximately 30 days after last dose (cycle length=28 days) ]

Other Outcome Measures:
1. Immunohistochemical assessment of tumor biopsies for the expression of Neuropilin-1 in order to study if the response to CEND-1 therapy can be predicted based on the Neuropilin-1 expression level
[ Time Frame: Screening Phase (Day -14 until Day -1) ]

Analysis of paraffin-embedded tumor tissues (also potentially in liquid-nitrogen frozen tissue, if available) will be performed to characterize Neuropilin-1 expression by immunohistochemistry (IHC) and potentially other analysis techniques.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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, OR 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.

Exclusion Criteria:

  • 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
Open or close this module Contacts/Locations
Central Contact Person: DrugCendR Call Center
Telephone: 9495058535
Email: info@drugcendr.com
Locations: Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Contact:Contact: Philip Beale 0061297676354‬ philip.beale@health.nsw.gov.au
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Contact:Contact: Mark Wong 0061298455200‬ ka.wong@sydney.edu.au
Australia, South Australia
Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Contact:Contact: Timothy Price 0061882228429‬ timothy.price@sa.gov.au
Australia, Western Australia
St John of God Hospital
Subiaco, Western Australia, Australia, 6008
Contact:Contact: Andrew Dean 0061893817793‬ andrew.dean@sjog.org.au
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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