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

Sponsor
Veloxis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05251727
Collaborator
(none)
80
Enrollment
15
Locations
6
Arms
29.3
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: thrombomodulin alfa
  • Drug: Placebo
 Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lowest Dose

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)

Drug: thrombomodulin alfa
Weight based dose of reconstituted treatment
Other Names:
  • ART-123

    		•
    Experimental: Low Dose

    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)"

    Drug: thrombomodulin alfa
    Weight based dose of reconstituted treatment
    Other Names:
  • ART-123

    		•
    Experimental: Medium Dose

    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)"

    Drug: thrombomodulin alfa
    Weight based dose of reconstituted treatment
    Other Names:
  • ART-123

    		•
    Experimental: High Dose

    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)"

    Drug: thrombomodulin alfa
    Weight based dose of reconstituted treatment
    Other Names:
  • ART-123

    		•
    Experimental: Highest Dose

    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)"

    Drug: thrombomodulin alfa
    Weight based dose of reconstituted treatment
    Other Names:
  • ART-123

    		•
    Placebo Comparator: Placebo

    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)"

    Drug: Placebo
    Weight based dose of reconstituted treatment

    Outcome Measures

    Primary Outcome Measures

    1. Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks]

      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)

    2. Number and Percentage of Participants with Serious TEAEs [From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks]

      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

    3. Number and Percentage of Participants with TEAEs Leading to Death [From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks]

      Number and percentage of participants with TEAEs that resulted in death

    4. Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation [From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks]

      Number and percentage of participants with TEAEs that lead to discontinuation of IMP

    5. Number and Percentage of Participants with Bleeding Events [From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks]

      Number and percentage of participants experiencing bleeding events

    6. Number and Percentage of Participants with Serious Bleeding Events [From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks]

      Number and percentage of participants with bleeding events that represent serious adverse events

    7. Number and Percentage of Participants with Dose Limiting Toxicity (DLT) [From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks]

      Number and percentage of participants experiencing DLT

    8. Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results [6 weeks]

      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

    9. Number and Percentage of Participants with Abnormal Serum Chemistry Results [6 weeks]

      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)

    10. Number and Percentage of Participants with Abnormal Coagulation Panel Results [6 weeks]

      Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT)

    11. Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results [6 weeks]

      Qualitative summary of the following by cohort: protein, glucose, and occult blood

    12. Number and Percentage of Participants with Abnormal Vital Signs [6 weeks]

      Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure

    13. Number and Percentage of Participants with Anti-ART-123 Antibodies [6 weeks]

      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

    1. Plasma Concentrations of Thrombomodulin [Cycle 1, Day 1 (each cycle is 14 days)]

      Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days)

    2. Plasma Concentrations of 5-fluorouracil (5-FU) [Cycle 1, Day 1 (each cycle is 14 days)]

      Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)

    3. Plasma Concentrations of Oxaliplatin [Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)]

      Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)

    4. Serum Concentrations of Bevacizumab [Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)]

      Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site #113 Beverly Hills California United States 90210
    2 Site #111 Norwich Connecticut United States 06360
    3 Site #104 Orange City Florida United States 32763
    4 Site #101 Bethesda Maryland United States 20817
    5 Site #107 Billings Montana United States 59101
    6 Site #103 Portland Oregon United States 97239
    7 Site #114 Houston Texas United States 77024
    8 Site #203 Gifu-shi Japan
    9 Site #208 Kita-gun Japan
    10 Site #207 Kitakyushu-shi Japan
    11 Site #206 Kobe-shi Japan
    12 Site #202 Matsuyama-shi Japan
    13 Site #204 Osaka-shi Japan
    14 Site #209 Osaka-shi Japan
    15 Site #205 Sapporo-shi Japan

    Sponsors and Collaborators

    • Veloxis Pharmaceuticals

    Investigators

    • Study Director: Shailesh G. Chavan, MD, Veloxis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veloxis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05251727
    Other Study ID Numbers:
    • ART-123.PN101
    First Posted:
    Feb 23, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of May 27, 2022