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Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)

Primary Purpose

Sarcoma,Soft Tissue, Gynecologic Cancer

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
AL3818
Sponsored by
Advenchen Laboratories, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Sarcoma,Soft Tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients. Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818. Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug. Patient is willing and able to sign a new informed consent. Patients for whom the Investigator believes can benefit from continuing to receive AL3818 Exclusion Criteria: Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial. Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2022
    Last Updated
    November 22, 2022
    Sponsor
    Advenchen Laboratories, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05612191
    Brief Title
    Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)
    Official Title
    An Open Label Post-Trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride Mono or in Combination Therapies in Patients Who Have Completed an Advenchen Sponsored Oncology Study With AL3818 (A Compassionate Use Trial)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advenchen Laboratories, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    Catequentinib (AL3818, Anlotinib) has been developed in a variety of clinical studies as single agents or in combination with others. This trial is designed to offer patients who completed an Advenchen sponsored AL3818 related study without progression the opportunity to continue to receive this investigational product in this Post-Trial Access study (a compassionate use trial), if the Investigator believes the patients can benefit from such a treatment and the patients have signed the Informed Consent Form.
    Detailed Description
    This is an open label trial and is designed to offer patients who are in a completed Advenchen sponsored AL3818 study without progression the opportunity to continue to receive AL3818. Qualified patients will continue therapy on their regimen established in the approved parent AL3818 clinical study until disease progression, physician decision, patient withdrawal, or sponsor discontinuation of the study. Dose modifications will be based on the suggestions in the approved parent AL3818 clinical study. Patients may be required to come to the site to receive AL3818. For patients who cannot come to the site to receive AL3818, the Site may mail the drug to the patient. The exact dispersing methods will be based on the Investigator's discretion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcoma,Soft Tissue, Gynecologic Cancer

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    AL3818
    Other Intervention Name(s)
    Catequentinib (AL3818, Anlotinib) Hydrochloride
    Intervention Description
    It inhibits VEGFR2-mediated downstream signal transduction, thereby inhibiting tumor angiogenesis. It also has high potency against FGFr as well as VEGFr, and as such acts as a mainly dual inhibitor.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients. Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818. Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug. Patient is willing and able to sign a new informed consent. Patients for whom the Investigator believes can benefit from continuing to receive AL3818 Exclusion Criteria: Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial. Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Judy Chen
    Phone
    8055301550
    Email
    info@advenchen.com

    12. IPD Sharing Statement

    Learn more about this trial

    Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)

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