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A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Withdrawn
Phase
Phase 2
Locations
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
  • Unresectable 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:

  • Prior treatment history with nerve toxic chemotherapeutic agent
  • Peripheral neuropathy or central nervous system damage
  • Psychiatric disorder
  • 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low Dose

    High Dose

    Placebo

    Arm Description

    Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

    Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

    Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

    Outcomes

    Primary Outcome Measures

    FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
    Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9

    Secondary Outcome Measures

    FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
    Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months
    FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)
    Proportion of subjects scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
    FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
    Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9
    FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
    Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9
    NRS (Pain) Scores (feet) at Cycle 9
    Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
    NRS (Pain) Scores (hands) at Cycle 9
    Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
    Side Effect Questionnaire Score
    Change from baseline score of Side effect questionnaire at the end of Cycle 9
    CTCAE: Peripheral Sensory Neuropathy
    Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
    CTCAE: Peripheral Motor Neuropathy
    Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
    mTCNS Score
    Change from baseline in total score of mTCNS at the end of Cycle 9
    Grooved Pegboard Change
    Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9
    EQ-5D-5L Change
    Change from baseline in EQ-5D-5L index value at the end of Cycle 9

    Full Information

    First Posted
    July 22, 2020
    Last Updated
    February 2, 2022
    Sponsor
    Veloxis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04492436
    Brief Title
    A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study design was changed
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    July 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 efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy
    Detailed Description
    To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Dose
    Arm Type
    Experimental
    Arm Description
    Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
    Arm Title
    High Dose
    Arm Type
    Experimental
    Arm Description
    Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    thrombomodulin alfa
    Other Intervention Name(s)
    ART-123
    Intervention Description
    Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
    Primary Outcome Measure Information:
    Title
    FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
    Description
    Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Secondary Outcome Measure Information:
    Title
    FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
    Description
    Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months
    Time Frame
    9 months
    Title
    FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)
    Description
    Proportion of subjects scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
    Description
    Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
    Description
    Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    NRS (Pain) Scores (feet) at Cycle 9
    Description
    Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    NRS (Pain) Scores (hands) at Cycle 9
    Description
    Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    Side Effect Questionnaire Score
    Description
    Change from baseline score of Side effect questionnaire at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    CTCAE: Peripheral Sensory Neuropathy
    Description
    Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    CTCAE: Peripheral Motor Neuropathy
    Description
    Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    mTCNS Score
    Description
    Change from baseline in total score of mTCNS at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    Grooved Pegboard Change
    Description
    Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)
    Title
    EQ-5D-5L Change
    Description
    Change from baseline in EQ-5D-5L index value at the end of Cycle 9
    Time Frame
    Cycle 9 (each cycle is 2 weeks)

    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 Unresectable 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: Prior treatment history with nerve toxic chemotherapeutic agent Peripheral neuropathy or central nervous system damage Psychiatric disorder 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Fineberg, MD
    Organizational Affiliation
    Veloxis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

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