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Talazoparib + Temozolomide for Small Cell Lung Cancer
Study Summary
This trial is studying talazoparib and temozolomide to treat extensive-stage small cell lung cancer.
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 agree not to donate sperm or eggs during and up to 105/45 days after my treatment.I am capable of understanding and agreeing to the trial's terms.I have recovered from previous treatment side effects, except for hair loss or acceptable lab results.I haven't had another cancer, except certain types, in the last 2 years.My blood clotting time is normal or managed if I'm on blood thinners.My cancer worsened after initial strong chemotherapy.I haven't taken any experimental drugs in the last 14 days.I have had radiation therapy to the chest or brain before.My cancer returned within 6 months or didn't respond to initial platinum-based treatment.I can take pills, have no allergies to the study drugs, and can follow the study rules.My kidney function is good, with a filtration rate of at least 30 mL/min.I am not pregnant and agree to use effective birth control during and 45 days after the study.My blood clotting time is normal or managed with medication.I have been treated with a PARP inhibitor or temozolomide before.I will use a condom during the study and for 105 days after it ends.I am not breastfeeding and will not for 45 days after the last treatment.Your absolute neutrophil count is at least 1,500 per microliter of blood.My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.I have been diagnosed with myelodysplastic syndrome.I have not had major surgery in the last 14 days.I am fully active or can carry out light work.I have previously received immunotherapy or targeted therapies.You must have at least 100,000 platelets per microliter of blood.I haven't used cancer drugs in the last 14 days.My lung cancer is confirmed to be extensive-stage small cell type.I have undergone more than one round of chemotherapy.I have a stomach or intestine condition that affects how my body absorbs food.I am not using and do not plan to use certain medications that could affect my treatment.You have a tumor that can be measured according to specific guidelines.I can provide a tissue sample for testing.My liver function tests are within the required range.Your bilirubin levels in the blood should not be higher than a certain limit.I have not had radiation therapy in the last 14 days, except for a one-time treatment for symptom relief.
- Group 1: Treatment (temozolomide, talazoparib)
- 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
Is this clinical experiment currently accessible to participants?
"As indicated on clinicaltrials.gov, this particular medical trial has ceased recruiting participants. It was initially posted on October 31st 2018 and the latest update is dated February 7th 2022. Despite this, there are still 4110 other studies actively looking for volunteers to participate in their investigations."
Has the FDA endorsed Talazoparib as a viable therapeutic option?
"According to our internal evaluation, talazoparib's safety was rank a 2 since this is a Phase 2 trial. This implies that there is only limited evidence of its security but no data demonstrating its efficiency."
How widely dispersed are the research centers conducting this experiment across the state?
"Patients can enroll in this research trial at locations such as the Cancer Center of Kansas in Wichita, Kansas, St. Joseph Heritage Healthcare in Fullerton, Indiana or Ft. Wayne Medical Oncology and Hematology Inc., located in Fort Wayne, Florida among other sites."
What is the current enrollment size for this research project?
"At the present moment, this trial is not recruiting any new patients. It was posted on October 31st 2018 and last edited on February 7th 2022. However, there are currently 3849 trials enrolling participants with carcinoma and 261 studies involving Talazoparib that have open enrolment."
What indications are commonly treated with Talazoparib?
"Talazoparib is a viable treatment option for patients with nitrosourea resistant, advanced mycosis fungoides and those who have already completed advance directives."
To what extent have there been other experiments involving Talazoparib?
"Currently, 261 clinical trials are running for Talazoparib. Of those studies, 27 have advanced to Phase 3. Despite the majority of these research projects being based in Seoul and Songpa, there is a total of 7056 locations conducting them worldwide."
Has a similar endeavor been undertaken before this one?
"Talazoparib has had a long history with clinical trials, beginning in 2002. Initially sponsored by Schering-Plough, the Phase 1 trial included 60 patients and was successful enough to prompt further research into this medication. Nowadays there are 261 active studies utilizing Talazoparib occurring in 1280 cities across 45 nations."
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