Compassionate Use Trial of Catequentinib for Patients Who Completed an Advenchen Study

Sponsor: Advenchen Laboratories, LLC

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05612191

Provider View

This trial allows patients who have completed a previous study with the drug Catequentinib (AL3818) and have not experienced disease progression to continue receiving the treatment if it is believed to be beneficial.

Patient Parameters

Program Overview

The purpose of this study is to provide continued access to the investigational drug Catequentinib (AL3818) for patients who have completed an Advenchen-sponsored study without their disease getting worse. This compassionate use trial is for patients who may still benefit from the treatment, as determined by their doctor, and who agree to participate by signing a consent form.

Description

This open-label trial is designed to allow patients who have completed an Advenchen-sponsored study with Catequentinib (AL3818) and have not experienced disease progression to continue receiving the drug. Patients will continue their established treatment plan from the previous study until their disease progresses, their doctor decides to stop, they choose to withdraw, or the study is discontinued by the sponsor. The dosage may be adjusted based on guidelines from the original study. Patients may need to visit the study site to receive the drug, but if they are unable to do so, the medication may be mailed to them, depending on the doctor's decision.

Eligibility Criteria

Inclusion Criteria

  • Currently receiving Catequentinib (AL3818) treatment from a previous approved study.
  • Have stable disease, partial response, or complete response based on the latest tumor assessment. If the disease has progressed, the doctor believes continuing the treatment could still be beneficial.
  • Female patients who can become pregnant and male partners must agree to use effective birth control during the study and for 4 months after the last dose.
  • Willing and able to sign a new consent form.
  • The doctor believes the patient can benefit from continuing the treatment.

Exclusion Criteria

  • Stopped previous Catequentinib (AL3818) treatment more than 3 weeks before joining this trial.
  • Disease progressed while on Catequentinib (AL3818) in the previous study, unless the doctor believes continuing the treatment could still be beneficial.

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