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Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer (VIRAGE)

Primary Purpose

Pancreatic Adenocarcinoma, Metastatic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nab-paclitaxel
Gemcitabine
VCN-01
Sponsored by
Theriva Biologics SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Cancer, Pancreatic adenocarcinoma, metastatic, oncolytic virus, VCN-01, Gemcitabine, Nab-Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent obtained prior to any study-specific procedures or assessments. Male/female patients aged 18 years or over. Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1. Patients willing to comply with the study treatment. Patients with a minimum life expectancy of 5 months. ECOG performance status of 0 or 1. Use of a reliable method of contraception in fertile men and women. Female patients of childbearing potential (i.e., female patients who are not postmenopausal or surgically sterile) must agree to use effective contraception. Male patients must agree to use effective contraception or be surgically sterile. Adequate baseline organ function (hematologic, liver, renal and nutritional) within 1 week of randomization: Hematology: Absolute neutrophil count ≥1.5xE9 /L Hemoglobin ≥9 g/dL Platelets ≥100x109/L Coagulation (*except in patients on anticoagulants): Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN) Activated partial thromboplastin time ≤1.2xULN Hepatic: Total bilirubin ≤1.5xULN ALT and AST ≤2.5xULN (if there are no liver metastases) ALT and AST <5xULN, and bilirubin <1.5xULN (if there are liver metastases) Renal: • Serum creatinine ≤1.5xULN, and if >1.5xULN: Estimated creatinine clearance >50 mL/min using Cockcroft and Gault formula Nutritional: • Serum Albumin ≥30 g/L Exclusion Criteria: Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons. Active infection or other serious illness or autoimmune disease at the moment of randomization. Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment. Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspect of hepatic fibrosis, a fibroscan must be performed; patients with a value ≥9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis. Treatment with another investigational agent within five of that treatment's half-lives prior to infusion of study treatment. Viral syndrome diagnosed during the 2 weeks before start of study treatment administration. Chronic immunosuppressive therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum). Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years. Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids, patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases). Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency. A female patient, who is pregnant or lactating. Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded. Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included. Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures. Patients with previous pneumonitis or interstitial lung disease. Patients with pre-existing sensory neuropathy >G1. Patients with known risk factors for bowel perforation, i.e., history of diverticulitis, intra-abdominal abscess, intestinal obstruction or abdominal carcinomatosis. Patients with QT interval corrected by Fridericia (QTcF) assessment >450 ms for men or >470 ms for women and left ventricular ejection fraction (LVEF) evaluation less than 50% measured by ECHO or multigated acquisition scan.

Sites / Locations

  • Hoag Memorial Hospital PresbyterianRecruiting
  • University of California - Davis Cancer CenterRecruiting
  • University of Lousville - Brown Cancer CenterRecruiting
  • Weill Cornell Medical CenterRecruiting
  • Huntsman Cancer Institute, University of UtahRecruiting
  • Hospital Duran i Reynals (ICO)Recruiting
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Gregorio MarañonRecruiting
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital General Univesitario de ValenciaRecruiting
  • Hospital Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1-SoC

Arm 2 -VCN-01 + SoC

Arm Description

Nab-paclitaxel and gemcitabine as SoC.

A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.

Outcomes

Primary Outcome Measures

Overall Survival
Time from randomization until death in both arms
Incidence of Adverse Events after VCN-01 IV administration
Safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm 2 measured as incidence of Adverse Events as assessed by CTCAE v4.0

Secondary Outcome Measures

Time to progression (TTP) or Progression Free Survival (PFS)
Overall Response Rate (ORR)
Objective response rate (ORR) defined as the sum of patients who achieved partial response (PR) plus patients who achieved complete response (CR) using RECIST version 1.1 criteria.
Disease Control Rate (DCR)
Disease Control Rate (DCR) defined as: stable disease (SD) + partial response (PR) + complete response (CR)
1-year survival
Progression Free Survival (PFS) at the 1-year landmark
Time from randomization to either progression or death from any cause.
Duration of Response (DoR)
Time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.
Changes in tumor marker Ca 19.9
Tumor marker Ca 19.9 measured every 4 weeks while on study

Full Information

First Posted
November 3, 2022
Last Updated
August 22, 2023
Sponsor
Theriva Biologics SL
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1. Study Identification

Unique Protocol Identification Number
NCT05673811
Brief Title
Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer
Acronym
VIRAGE
Official Title
A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
April 28, 2025 (Anticipated)
Study Completion Date
April 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theriva Biologics SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
Detailed Description
Multi-center, open label, randomized, 2-parallel arm, phase IIb study of nab-paclitaxel and gemcitabine as SoC plus/minus VCN-01 in patients with metastatic pancreatic cancer. VCN-01 is a genetically modified adenovirus characterised by the presence of four independent genetic modifications on the backbone of the wild-type human adenovirus serotype 5 (HAd5) genome that confer tumor selective replication and antitumor activity. Approximately 92 patients in sites in North America and European Union (EU) will be recruited and randomized in a 1:1 ratio to one of two treatment arms (i.e., approximately 46 patients per treatment arm): Arm 1- (SoC): Nab-paclitaxel and gemcitabine as SoC (28-day cycles). Patients in this arm will not receive the IMP (VCN-01). Arm 2- (VCN-01+ SoC): A maximum of two (2) doses of VCN-01 administrated in combination with nab-paclitaxel and gemcitabine as SoC (28 day cycles with exception of the IMP dose cycles, which will be 35-day cycles). A Data Monitoring Committee (DMC) will be convened at regular intervals to assess safety and to look at OS to determine if the trial can continue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Metastatic
Keywords
Cancer, Pancreatic adenocarcinoma, metastatic, oncolytic virus, VCN-01, Gemcitabine, Nab-Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1-SoC
Arm Type
Active Comparator
Arm Description
Nab-paclitaxel and gemcitabine as SoC.
Arm Title
Arm 2 -VCN-01 + SoC
Arm Type
Experimental
Arm Description
A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel administered as a 30- to 40-minute IV infusion at a rate of 125 mg/m2. Nab-paclitaxel is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine administered at a rate of 1,000 mg/m2 and infused through a 30-minute IV infusion immediately after the completion of nab-paclitaxel administration as part of SoC. Gemcitabine is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.
Intervention Type
Genetic
Intervention Name(s)
VCN-01
Intervention Description
VCN-01 administrated as a single IV infusion at dose 1xE13 vp/patient, over a period of 10 minutes on Day 1 of the 1st cycle and then again on Day 1 of the 4th cycle (Day 92). On cycle 1 and cycle 4, nab-paclitaxel and gemcitabine administered on Day 8, Day 15 and Day 22.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization until death in both arms
Time Frame
From randomization until death for any cause up to 3 years
Title
Incidence of Adverse Events after VCN-01 IV administration
Description
Safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm 2 measured as incidence of Adverse Events as assessed by CTCAE v4.0
Time Frame
From randomization until disease progression assessed up to 3 years
Secondary Outcome Measure Information:
Title
Time to progression (TTP) or Progression Free Survival (PFS)
Time Frame
From randomization until disease progression assessed up to 3 years
Title
Overall Response Rate (ORR)
Description
Objective response rate (ORR) defined as the sum of patients who achieved partial response (PR) plus patients who achieved complete response (CR) using RECIST version 1.1 criteria.
Time Frame
From randomization until death for any cause up to 3 years
Title
Disease Control Rate (DCR)
Description
Disease Control Rate (DCR) defined as: stable disease (SD) + partial response (PR) + complete response (CR)
Time Frame
From randomization until death for any cause up to 3 years
Title
1-year survival
Time Frame
From randomization to 1-year landmark
Title
Progression Free Survival (PFS) at the 1-year landmark
Description
Time from randomization to either progression or death from any cause.
Time Frame
From randomization to1-year landmark
Title
Duration of Response (DoR)
Description
Time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.
Time Frame
From randomization to disease progression assessed up to 3 years
Title
Changes in tumor marker Ca 19.9
Description
Tumor marker Ca 19.9 measured every 4 weeks while on study
Time Frame
From randomization until disease progression assessed up to 3 years
Other Pre-specified Outcome Measures:
Title
Neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs)
Description
Determination of neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs) in serum of Arm 2 patients at different time-points during the study
Time Frame
From pre-dose up to 3 years
Title
PH20 levels in serum
Description
Determination of PH20 levels in serum of Arm 2 (VCN-01 + SoC) patients at the following time-points: Cycle 1 (VCN-01+SoC dosing): Pre-dose, 48h post-dose and on day 8; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose, 48h post-dose and on day 8; On Day 1 of any subsequent SoC cycle.
Time Frame
From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
Title
VCN-01 genomes levels in blood
Description
Determination of VCN-01 genomes in blood of Arm 2 (VCN-01 + SoC) patients at the following time-points: Cycle 1 (VCN-01+SoC dosing): Pre-dose, 48h post-dose, on day 8 and day 15; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose, 48h post-dose, on day 8 and day 15; On Day 1 of any subsequent SoC cycle.
Time Frame
From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
Title
Immune markers
Description
Determination of immune markers in serum of Arm 2 (VCN-01 + SoC) patients at the following time-points: Cycle 1 (VCN-01+SoC dosing): Pre-dose, 4h and 48h post-dose and on day 8; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose, 4h and 48h post-dose, on day 8 and day 25; On Day 1 of any subsequent SoC cycle.
Time Frame
From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
Title
Radionics
Description
Change in radionics assessed from the images of CT scans or MRI.
Time Frame
Changes from baseline to every 8 week or every 4 weeks if there is a suspicion of Progressive Disease (PD) not radiologically confirmed during treatment and until disease progression up to 3 years.
Title
Tumor growth
Description
Change in tumor growth assessed from the images of CT scans or MRI.
Time Frame
Changes from baseline to every 8 week or every 4 weeks if there is a suspicion of Progressive Disease (PD) not radiologically confirmed during treatment and until disease progression up to 3 years.
Title
Changes in Quality of Life (QoL) via the validated Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) version 3.
Description
Changes in QoL assessed as the difference between QoL in day 1 of 1st treatment cycle (35 d) to QoL in day 1 of Cycle 2 (28d), to QoL in day 1 of Cycle 3 (28d), to QoL in day 1 of Cycle 4 (35d) and to QoL in day 1 of any subsequent SoC cycle (28d). Changes in QoL in EoT visit (1 month after last SoC treatment). Changes in QoL until disease progression in each monthly follow-up visit. After disease progression, changes in QoL in each monthly follow up visit during the first 6 months; changes in bimonthly follow-up visits up to to 2 from progression and changes in each follow-up visit every 6 months onwards. The QoL scale ranges in score from 0 to 100, a high score represents a higher response level.
Time Frame
From Day 1 in first treatment cycle (35-days) to last follow-up visit up to 3 years.
Title
Disease Control Rate (DCR) to subsequent therapies
Description
Disease Control Rate (DCR) defined as: stable disease (SD) + partial response (PR) + complete response (CR)
Time Frame
From disease progression to exitus for any cause up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained prior to any study-specific procedures or assessments. Male/female patients aged 18 years or over. Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1. Patients willing to comply with the study treatment. Patients with a minimum life expectancy of 5 months. ECOG performance status of 0 or 1. Use of a reliable method of contraception in fertile men and women. Female patients of childbearing potential (i.e., female patients who are not postmenopausal or surgically sterile) must agree to use effective contraception. Male patients must agree to use effective contraception or be surgically sterile. Adequate baseline organ function (hematologic, liver, renal and nutritional) within 1 week of randomization: Hematology: Absolute neutrophil count ≥1.5xE9 /L Hemoglobin ≥9 g/dL Platelets ≥100x109/L Coagulation (*except in patients on anticoagulants): Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN) Activated partial thromboplastin time ≤1.2xULN Hepatic: Total bilirubin ≤1.5xULN ALT and AST ≤2.5xULN (if there are no liver metastases) ALT and AST <5xULN, and bilirubin <1.5xULN (if there are liver metastases) Renal: • Serum creatinine ≤1.5xULN, and if >1.5xULN: Estimated creatinine clearance >50 mL/min using Cockcroft and Gault formula Nutritional: • Serum Albumin ≥30 g/L Exclusion Criteria: Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons. Active infection or other serious illness or autoimmune disease at the moment of randomization. Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment. Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspect of hepatic fibrosis, a fibroscan must be performed; patients with a value ≥9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis. Treatment with another investigational agent within five of that treatment's half-lives prior to infusion of study treatment. Viral syndrome diagnosed during the 2 weeks before start of study treatment administration. Chronic immunosuppressive therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum). Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years. Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids, patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases). Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency. A female patient, who is pregnant or lactating. Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded. Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included. Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures. Patients with previous pneumonitis or interstitial lung disease. Patients with pre-existing sensory neuropathy >G1. Patients with known risk factors for bowel perforation, i.e., history of diverticulitis, intra-abdominal abscess, intestinal obstruction or abdominal carcinomatosis. Patients with QT interval corrected by Fridericia (QTcF) assessment >450 ms for men or >470 ms for women and left ventricular ejection fraction (LVEF) evaluation less than 50% measured by ECHO or multigated acquisition scan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Cascallo, PhD
Phone
+34 93 571 2359
Email
MCascallo@therivabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Kaleko, MD, PhD
Phone
+1 3014174364
Email
mkaleko@therivabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Blasco, PhD
Organizational Affiliation
Theriva Biologics S.L.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mary Ann Shallcross, PhD
Organizational Affiliation
Theriva Biologics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara E Seery, MD
Facility Name
University of California - Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Kim, M.D., PhD
Facility Name
University of Lousville - Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek R. Sharma, MD, FACP
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alana T H Nguyen, MD, PhD
Facility Name
Huntsman Cancer Institute, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Garrido-Laguna, MD, PhD
Facility Name
Hospital Duran i Reynals (ICO)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berta Laquente, MD, PhD
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Martinez de Castro, MD, PhD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Macarulla, MD, PhD
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Muñoz, MD, PhD
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Guillén Ponce, MD., PhD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocío García, MD, PhD
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireya Cazorla, MD, PhD
Facility Name
Hospital General Univesitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Lobo, MD, PhD
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Pazo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

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