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

NCT05612191 | Unknown

• 1 other identifier: AL3818-PTA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcoma,Soft Tissue; Gynecologic Cancer

Interventions

AL3818 DRUG

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.

Also known as: Catequentinib (AL3818, Anlotinib) Hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advenchen Laboratories, LLC: lead

MeSH Terms

Conditions

Sarcoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Judy Chen

CONTACT

8055301550; info@advenchen.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 10, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11