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Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
thrombomodulin alfa
Placebo
Sponsored by
Veloxis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
  • ECOG performance status of 0 or 1
  • The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
  • Able to sufficiently understand the clinical study and give written informed consent

Exclusion Criteria:

  • History of major hemorrhage
  • High risk of hemorrhage
  • History of other malignancies
  • Active ulcer
  • Patients using anti-coagulants and fibrinolytic drugs
  • Active Hepatitis B, or known HBs antigen positive
  • Prior treatment history with thrombomodulin alfa
  • Administration of another investigational medicinal product within 30 days prior to randomization
  • Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
  • Patients otherwise deemed as inappropriate to participate in the study by the Investigator

Sites / Locations

  • Beverly Hills Cancer CenterRecruiting
  • UCLA Dept. of Medicine - Hematology/OncologyRecruiting
  • Eastern Connecticut Hematology & Oncology AssociatesRecruiting
  • Mid-Florida Hematology & Oncology CentersRecruiting
  • Horizon Oncology Research, Inc.Recruiting
  • American Oncology Partners of MarylandRecruiting
  • St. Vincent Frontier Cancer CenterRecruiting
  • Englewood Hospital and Medical CenterRecruiting
  • Site #115
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Prisma Health Cancer InstituteRecruiting
  • Nashville Oncology Associates, PCRecruiting
  • Site #120
  • Site #114
  • MultiCare Regional Cancer CenterRecruiting
  • NHO Kyushu Cancer CenterRecruiting
  • Gifu University HospitalRecruiting
  • Kagawa University HospitalRecruiting
  • Kitakyushubyoin Kitakyusyu General HospitalRecruiting
  • Kumpukai Sano HospitalRecruiting
  • NHO Shikoku Cancer CenterRecruiting
  • Kochi Medical School HospitalRecruiting
  • NHO Osaka National HospitalRecruiting
  • Osaka General Medical CenterRecruiting
  • Tonan HospitalRecruiting
  • Shizuoka Cancer CenterRecruiting
  • University of Tsukuba HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lowest Dose

Low Dose

Medium Dose

High Dose

Highest Dose

Placebo

Arm Description

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Outcomes

Primary Outcome Measures

Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP)
Number and Percentage of Participants with Serious TEAEs
Number and percentage of participants experiencing one or more serious adverse events which occurred or worsened in severity after the start of the first dose of IMP
Number and Percentage of Participants with TEAEs Leading to Death
Number and percentage of participants with TEAEs that resulted in death
Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation
Number and percentage of participants with TEAEs that lead to discontinuation of IMP
Number and Percentage of Participants with Bleeding Events
Number and percentage of participants experiencing bleeding events
Number and Percentage of Participants with Serious Bleeding Events
Number and percentage of participants with bleeding events that represent serious adverse events
Number and Percentage of Participants with Dose Limiting Toxicity (DLT)
Number and percentage of participants experiencing DLT
Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
Descriptive statistics will summarize the following by cohort: red blood cell count, hemoglobin, hematocrit, white blood cell count, white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count
Number and Percentage of Participants with Abnormal Serum Chemistry Results
Descriptive statistics will summarize the following by cohort: aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total protein, albumin, blood urea nitrogen, creatinine, glucose, and electrolytes (sodium, potassium, chloride)
Number and Percentage of Participants with Abnormal Coagulation Panel Results
Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT)
Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
Qualitative summary of the following by cohort: protein, glucose, and occult blood
Number and Percentage of Participants with Abnormal Vital Signs
Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure
Number and Percentage of Participants with Anti-ART-123 Antibodies
Number and Percentage of Participants with detectable anti-ART-123 antibodies; samples testing positive for anti-ART-123 antibodies will be tested for the presence of neutralizing antibodies

Secondary Outcome Measures

Plasma Concentrations of Thrombomodulin
Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days)
Plasma Concentrations of 5-fluorouracil (5-FU)
Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)
Plasma Concentrations of Oxaliplatin
Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)
Serum Concentrations of Bevacizumab
Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)

Full Information

First Posted
January 7, 2022
Last Updated
July 19, 2023
Sponsor
Veloxis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05251727
Brief Title
Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
Official Title
Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veloxis Pharmaceuticals

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
To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Detailed Description
To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lowest Dose
Arm Type
Experimental
Arm Description
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Arm Title
Medium Dose
Arm Type
Experimental
Arm Description
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Arm Title
Highest Dose
Arm Type
Experimental
Arm Description
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Intervention Type
Drug
Intervention Name(s)
thrombomodulin alfa
Other Intervention Name(s)
ART-123
Intervention Description
Weight based dose of reconstituted treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Weight based dose of reconstituted treatment
Primary Outcome Measure Information:
Title
Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP)
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks
Title
Number and Percentage of Participants with Serious TEAEs
Description
Number and percentage of participants experiencing one or more serious adverse events which occurred or worsened in severity after the start of the first dose of IMP
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Title
Number and Percentage of Participants with TEAEs Leading to Death
Description
Number and percentage of participants with TEAEs that resulted in death
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Title
Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation
Description
Number and percentage of participants with TEAEs that lead to discontinuation of IMP
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks
Title
Number and Percentage of Participants with Bleeding Events
Description
Number and percentage of participants experiencing bleeding events
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Title
Number and Percentage of Participants with Serious Bleeding Events
Description
Number and percentage of participants with bleeding events that represent serious adverse events
Time Frame
From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Title
Number and Percentage of Participants with Dose Limiting Toxicity (DLT)
Description
Number and percentage of participants experiencing DLT
Time Frame
From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks
Title
Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
Description
Descriptive statistics will summarize the following by cohort: red blood cell count, hemoglobin, hematocrit, white blood cell count, white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count
Time Frame
6 weeks
Title
Number and Percentage of Participants with Abnormal Serum Chemistry Results
Description
Descriptive statistics will summarize the following by cohort: aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total protein, albumin, blood urea nitrogen, creatinine, glucose, and electrolytes (sodium, potassium, chloride)
Time Frame
6 weeks
Title
Number and Percentage of Participants with Abnormal Coagulation Panel Results
Description
Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT)
Time Frame
6 weeks
Title
Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
Description
Qualitative summary of the following by cohort: protein, glucose, and occult blood
Time Frame
6 weeks
Title
Number and Percentage of Participants with Abnormal Vital Signs
Description
Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure
Time Frame
6 weeks
Title
Number and Percentage of Participants with Anti-ART-123 Antibodies
Description
Number and Percentage of Participants with detectable anti-ART-123 antibodies; samples testing positive for anti-ART-123 antibodies will be tested for the presence of neutralizing antibodies
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Plasma Concentrations of Thrombomodulin
Description
Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days)
Time Frame
Cycle 1, Day 1 (each cycle is 14 days)
Title
Plasma Concentrations of 5-fluorouracil (5-FU)
Description
Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)
Time Frame
Cycle 1, Day 1 (each cycle is 14 days)
Title
Plasma Concentrations of Oxaliplatin
Description
Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)
Time Frame
Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)
Title
Serum Concentrations of Bevacizumab
Description
Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)
Time Frame
Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum ECOG performance status of 0 or 1 The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study Able to sufficiently understand the clinical study and give written informed consent Exclusion Criteria: History of major hemorrhage High risk of hemorrhage History of other malignancies Active ulcer Patients using anti-coagulants and fibrinolytic drugs Active Hepatitis B, or known HBs antigen positive Prior treatment history with thrombomodulin alfa Administration of another investigational medicinal product within 30 days prior to randomization Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period Patients otherwise deemed as inappropriate to participate in the study by the Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Liu, MD PhD
Organizational Affiliation
Veloxis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
UCLA Dept. of Medicine - Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Eastern Connecticut Hematology & Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Mid-Florida Hematology & Oncology Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Horizon Oncology Research, Inc.
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
American Oncology Partners of Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Site #115
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Sloan Kettering Cancer 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
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Nashville Oncology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
Site #120
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site #114
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Withdrawn
Facility Name
MultiCare Regional Cancer Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
984-301-2320
Email
pal@veloxis.com
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Gifu University Hospital
City
Gifu-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Kagawa University Hospital
City
Kita-gun
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Kitakyushubyoin Kitakyusyu General Hospital
City
Kitakyushu-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Kumpukai Sano Hospital
City
Kobe-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
NHO Shikoku Cancer Center
City
Matsuyama-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Kochi Medical School Hospital
City
Nankoku-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
NHO Osaka National Hospital
City
Osaka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Osaka General Medical Center
City
Osaka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Tonan Hospital
City
Sapporo-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com
Facility Name
University of Tsukuba Hospital
City
Tsukuba-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Allton
Phone
010-1-984-301-2320
Email
pal@veloxis.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

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