This clinical trial is focused on studying the effects of a medication called Navtemadlin as a maintenance therapy for patients with a specific type of cancer known as Advanced or Recurrent Endometrial Cancer. This type of cancer affects the lining of the uterus and can either be advanced, meaning it has spread beyond the uterus, or recurrent, meaning it has returned after treatment. The study aims to determine the appropriate dose of Navtemadlin and to compare its effectiveness in prolonging the time patients live without the cancer worsening, compared to a placebo.
The study involves two parts. In the first part, researchers will determine the best dose of Navtemadlin to use in the second part of the study. In the second part, participants will receive either Navtemadlin or a placebo to see which is more effective in keeping the cancer from progressing. The study will also monitor the safety of Navtemadlin and any side effects that may occur. Participants will take the medication orally in the form of tablets.
Other medications involved in the study include Loperamide and Ondansetron, which are used to manage symptoms and side effects. Loperamide is typically used to treat diarrhea, while Ondansetron is used to prevent nausea and vomiting. The study will last for a period of up to 24 months, during which participants will be closely monitored by healthcare professionals. The goal is to improve the quality of life and outcomes for patients with this type of cancer.
1joining the study
Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide informed consent, confirming your understanding and willingness to participate.
2initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and performing necessary tests to ensure you meet the study criteria.
3treatment phase part 1
In the first part of the treatment phase, you will receive the study medication navtemadlin orally. The dosage will be determined by the safety review committee based on safety data. You will be monitored for any side effects and your response to the treatment.
4treatment phase part 2
In the second part of the treatment phase, you will continue to receive navtemadlin or a placebo. The aim is to compare the progression-free survival between the two groups. You will be required to take the medication as prescribed and attend regular follow-up visits for monitoring.
5regular monitoring
Throughout the trial, you will undergo regular monitoring, including blood tests, imaging studies, and other assessments to track your health and the effectiveness of the treatment. Any changes in your condition will be documented.
6end of treatment
At the end of the treatment phase, a final assessment will be conducted to evaluate your overall response to the study medication. You will be informed about the next steps and any follow-up care required.
Who Can Join the Study?
Must be a female who is 18 years or older and able to give consent to participate.
Must have a confirmed diagnosis of endometrial cancer through specific medical tests.
Must have advanced or recurrent disease and have completed a specific type of chemotherapy, achieving either a complete or partial response.
Must be able to start the study treatment within 6 weeks after finishing the last dose of chemotherapy.
Must have an ECOG performance status of 0 to 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate blood cell counts and function, without needing support from growth factors for at least 7 days, except for a specific type of support which requires 14 days.
Must have adequate liver function, with specific limits on liver enzymes and bilirubin levels.
Must have adequate kidney function, with a creatinine clearance of at least 30 mL/min, which is a measure of how well the kidneys are working.
If of childbearing potential, must use a highly effective method of contraception during the study and for a specified period after the last dose of the study drug.
Who Cannot Join the Study?
Patients who have a different type of cancer than the one being studied, which is advanced or recurrent endometrial cancer.
Patients who are not within the specified age range for the study.
Patients who are male, as the study is only for female participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.
Navtemadlin is a medication being studied for its potential to help people with a specific type of endometrial cancer, which is a cancer that starts in the lining of the uterus. This medication is being tested as a maintenance therapy, which means it is used to help keep the cancer from coming back after it has responded to initial treatment with chemotherapy. The goal of using navtemadlin is to see if it can help patients live longer without their cancer getting worse. In this study, researchers are trying to find the best dose of navtemadlin and to see how well it works compared to not using any additional treatment after chemotherapy.
Advanced or Recurrent Endometrial Cancer – Endometrial cancer originates in the lining of the uterus, known as the endometrium. In advanced stages, the cancer has spread beyond the uterus to other parts of the body. Recurrent endometrial cancer refers to cancer that has returned after treatment. The disease progresses as cancer cells grow uncontrollably, potentially invading nearby tissues and organs. Over time, it may spread to distant parts of the body through the lymphatic system or bloodstream. The progression can lead to symptoms such as abnormal vaginal bleeding, pelvic pain, and weight loss.
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