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Talazoparib + Radiation for Gynecologic Cancers
Study Summary
This trial looks at the side effects and best dose of talazoparib when given with radiation therapy for treating patients with recurrent gynecologic cancers. Talazoparib may stop cancer growth by blocking some enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib with radiation therapy may work better in treating patients with gynecologic cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777Trial Design
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Who is running the clinical trial?
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- I am not taking medications like ketoconazole or ritonavir.I have a tumor that can be measured and has not been treated with radiation.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.Your recent blood test does not show signs of a specific type of blood disorder called myelodysplastic syndrome or acute myeloid leukemia.Your serum creatinine level is not more than 1.5 times the upper limit of normal.My cancer has returned in the vagina only, with no spread to lymph nodes or elsewhere.I have not had major surgery in the last 2 weeks or have fully recovered from it.My stage IV cancer is stable or undetectable outside the radiation area, and I can stop other treatments 3 weeks before starting the trial.I have lasting side effects from cancer treatment, but not hair loss.I am currently undergoing chemotherapy or radiotherapy.I have fluid in my abdomen, cancer spread in my abdomen lining, or liver metastases.I haven't had cancer treatments or experimental drugs in the last 3 weeks.I have had another type of cancer but it was treated successfully and I've been disease-free for over 5 years.I cannot swallow pills or have a stomach condition that affects medication absorption.I am not pregnant, cannot become pregnant, or am following strict birth control measures.My cancer is in the abdomen or pelvis and has come back after treatment.I do not have any serious uncontrolled health issues or infections.My liver function tests are within the required range.I am fully active or can carry out light work.I am willing and able to follow the study's treatment plan and attend all visits.My hemoglobin is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.I have brain metastases but they are under control and I've been on a stable dose of corticosteroids for at least 28 days.Your white blood cell count is higher than 3 x 10^9/L in the last 28 days before starting the study treatment.Your total bilirubin level must be less than 1.5 times the upper limit of normal at the hospital where you are being treated.Your platelet count is at least 100 billion per liter within the last 28 days before starting the study treatment.I have seizures that are not controlled by medication.I am not taking any medications that affect drug transport in the body.My ECG shows a QTc over 470 msec or I have a family history of long QT syndrome.I need radiotherapy in my pelvic and lower back area.You are expected to live for at least 16 weeks.Your white blood cell count is normal.You are allergic to talazoparib or any of the ingredients in the product.I have had radiotherapy in the same area where more is planned.
- Group 1: Treatment (talazoparib, radiation therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are engaged in this clinical exploration?
"Affirmative, the data available on clinicaltrials.gov suggests that this medical experiment is currently enrolling patients. Initially posted on September 26th 2019 and most recently edited June 6th 2022, 24 subjects are being sought from a single facility."
Has the FDA sanctioned Talazoparib for widespread use?
"The safety of Talazoparib is estimated to be a 1, as this trial is only in its preliminary stages. There exists limited data on both the efficacy and safety at this time."
Is this study actively enlisting participants at the present time?
"Affirmative. According to the information readily available on clinicaltrials.gov, this study is actively seeking participants. The research was first posted in September 2019 and underwent its last edit in June 2022. 24 individuals are needed for enrolment at one medical facility."
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