Sarcoma,Soft TissueNCT05612191
Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)
A study testing AL3818 in people with Sarcoma,Soft Tissue and Gynecologic Cancer, run by Advenchen Laboratories, LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue, Gynecologic Cancer
- What is being tested?
- AL3818
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
Read the 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
- Sarcoma,Soft Tissue, Gynecologic Cancer
- Being tested
- AL3818
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL3818Drug
Also called Catequentinib (AL3818, Anlotinib) Hydrochloride
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
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612191
- Sponsor's protocol ID
- AL3818-PTA
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05612191
- Acronym / sponsor ID
- AL3818-PTA
- Conditions
- Sarcoma,Soft Tissue, Gynecologic Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Advenchen Laboratories, LLCIndustry (pharma, biotech, devices)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL3818Also: Catequentinib (AL3818, Anlotinib) HydrochlorideIt 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
Related trials for Sarcoma,Soft Tissue
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing AL3818 in people with Sarcoma,Soft Tissue and Gynecologic Cancer, run by Advenchen Laboratories, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy Chen (8055301550, info@advenchen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.