Trials / Available
AvailableNCT05612191
Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)
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)
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Advenchen Laboratories, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL3818 | 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. |
Timeline
- First posted
- 2022-11-10
- Last updated
- 2022-11-28
Source: ClinicalTrials.gov record NCT05612191. Inclusion in this directory is not an endorsement.