NCT04553133

A clinical trial of a study medicine for people with advanced small cell lung cancer or advanced ovarian cancer

The C4161001 study is researching whether a study medicine is safe and effective in the treatment of advanced small cell lung cancer or advanced ovarian cancer.

Unfortunately, current treatment options are limited and may not work for everyone. Doctors are working to find better treatment options for people living with advanced small cell lung cancer or ovarian cancer.

Card Summary Component

Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned the C4161001 study to you, or perhaps you found your way here by yourself. Either way, thank you for your interest.

This study may be an option if you:

  • Are 18 years and older
  • Have been diagnosed with advanced small cell lung cancer or advanced ovarian cancer
  • Have received at least 1 anti-cancer therapy

There are other requirements to participate in this study. The study doctor will explain these to you.

Condition

Small cell lung cancer Ovarian cancer

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18 years or older

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If you decide to participate in this study, you will take the study medicine by mouth twice a day, in 28-day cycles. You will continue to receive the study medicine for as long as it is benefiting you.

You will need to attend regular visits so the study team can monitor how you are responding to the study medicine. These visits will include health assessments, tests and scans.

Length of study treatment

6 months or longer

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

At least 12 visits

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

Phone calls to check in every 2 months

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About small cell lung cancer

About small cell lung cancer

Small cell lung cancer (SCLC) is an aggressive type of lung cancer that accounts for about 15% of all lung cancer cases. SCLC usually starts in the breathing tubes (bronchi) in the center of the chest. Although the cancer cells are small, they grow very quickly and create large tumors. These tumors often spread (metastasize) to other part of the body, including the brain, liver and bones.

About ovarian cancer

About ovarian cancer

Ovarian cancer is a group of diseases that originates in a women’s ovaries, or in the related areas of the fallopian tubes and the peritoneum (the tissue lining that covers organs in the abdomen). Ovarian cancers come in a variety of different tumor types. The most common tumor type is high-grade serous carcinoma, accounting for about 70% of ovarian cancer cases.

Frequently asked questions

How long will I be in the study?

Time in the study will vary for everyone and depends on how your cancer responds to the study medicine. You may continue to receive the study medicine for as long as it is benefiting you. After completing the course of study medicine, you will need to continue with long term follow-up every two months.

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What are the benefits and risks?

Your cancer may get better, get worse, or stay the same. Your health will be closely monitored during the study. Participation may help people in the future by increasing our understanding of the investigational or study medicine and small cell lung cancer or ovarian cancer.

If your health gets worse, your study team and your study doctor will help you decide what to do, which may mean stopping your participation in the study. Potential risks from taking part in the study may include: side effects from taking the study medicine, for example diarrhea, nausea, fatigue; risks or discomforts from study procedures such as blood tests and body scans; risk of allergic reaction to the study medicine.

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