Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects with Recurrent or Metastatic Endometrial,Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.

This research trial is looking at a new treatment called AL3818. This drug is being tested in combination with standard platinum-based chemotherapy for women who have ovarian, fallopian tube, or primary peritoneal cancer that has returned or spread, and has been resistant to previous platinum treatments. The main goal is to see if adding AL3818 can help stop the cancer from growing or spreading for a longer time. Researchers will also be checking how many women respond to the treatment and how long they live. This is a large study (Phase 3), which typically means they are comparing the new treatment against the best existing treatment to see if it’s better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Advenchen Laboratories LLC

Enrolment target

100

Start

15 Nov 2024

Platinum resistant recurrent or metastatic ovarian fallopian or primary peritoneal cancer

What is this study about?

This study is designed to find out if a new medication called AL3818, when given with standard chemotherapy, can help women with certain types of gynaecological cancers. Specifically, it's for women who have ovarian, fallopian tube, or primary peritoneal cancer that has come back or spread, and has not responded well to, or has become resistant to, usual platinum-based chemotherapy treatments.

The main thing the researchers want to measure is how long people live without their cancer getting worse or spreading. This is often called 'Progression-Free Survival' (PFS). They will use scans to regularly check if the cancer is growing. An expert team who doesn't know which treatment each person is getting will look at these scans.

They will also be looking at other important things, like how many people's cancers shrink or disappear (this is called 'Objective Tumour Response Rate'), how long that response lasts, and how long people live overall. This is a 'Phase 3' study, which is the final stage of testing a new drug before it can be considered for wider use. It means they compare the new treatment against the best available standard treatment.

Key takeaways

New drug (AL3818) studied with standard chemotherapy.
For ovarian, fallopian tube, or primary peritoneal cancer that has returned or spread.
Specifically for cancer resistant to platinum chemotherapy.
Aims to see if it stops cancer growth for longer.
This is a late-stage clinical trial (Phase 3).

Who may be eligible?

This study is for women who are 18 years old or older. You would be considered if you have ovarian, fallopian tube, or primary peritoneal cancer that has either come back after treatment or spread to other parts of your body.

Importantly, your cancer must also be considered 'platinum-resistant'. This means it hasn't responded well to previous treatments that included a type of chemotherapy called platinum-based drugs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ovarian, fallopian tube, or primary peritoneal cancer?
Has your cancer come back or spread?
Has your cancer been resistant or stopped responding well to platinum-based chemotherapy?
Are you able to commit to regular hospital visits and assessments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic for treatments and check-ups. You would receive the study medication (AL3818) along with standard chemotherapy, as determined by the trial doctors. You would have regular scans to monitor your cancer and blood tests to check your general health.

There will be appointments to assess how you are feeling and to manage any side effects. After your treatment phase, there would be follow-up appointments to track your progress and long-term health. The exact number of visits and the full duration of your participation would be explained in more detail by the study team, but clinical trials usually involve a significant commitment over many months, sometimes years.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment that isn't yet widely available, which might be more effective than current options for your condition. However, new treatments can also have unknown side effects or might not work better than existing ones. You might experience side effects from the study drug, the chemotherapy, or the combination. All potential risks and benefits will be thoroughly explained to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy

Common questions

What is AL3818?

AL3818 is a new drug being tested to see if it can help stop cancer cells from growing. It works differently from standard chemotherapy.

What does 'platinum-resistant' mean?

It means your cancer hasn't responded well to previous treatments that used a type of chemotherapy called platinum-based drugs, or it has returned quickly after such treatment.

What kind of cancers is this study for?

This study is for women with ovarian, fallopian tube, or primary peritoneal cancer that has come back or spread.

What is a 'Phase 3' study?

A Phase 3 study is the final stage of testing a new treatment. It usually compares the new treatment with the best currently available treatment to see which is more effective and safer.

Will I definitely get the new drug?

In some 'Phase 3' trials, participants are randomly assigned to receive either the new drug combination or the standard treatment. The study team will explain how this works for this specific trial.