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Talazoparib + Temozolomide for Advanced Rare Cancers
Study Summary
This trial is testing whether a combination of two drugs, talazoparib and temozolomide, can shrink tumors in patients with rare cancers that have spread to other parts of the body.
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 do not have active brain cancer, and any brain metastases I had are stable without needing steroids or seizure medicine for at least 1 month.I had hepatitis B in the past but have recovered, with recent tests confirming this.I have a tumor that can be measured according to specific criteria.I agree to a biopsy on a tumor that can be safely sampled, separate from those measured for treatment response.My rare solid tumor has worsened despite treatment, or there are no standard treatments left for me.I am not eligible for higher priority clinical trials due to previous treatments.I do not have significant liver disease such as hepatitis or cirrhosis.My rare solid tumor has worsened despite treatment, or there are no standard treatments left for me.I am not eligible for higher priority studies due to previous treatments.I agree to a biopsy and my tumor can be safely biopsied.It has been over 3 weeks since I finished radiation therapy or had major surgery.I do not have any serious illnesses that my doctors haven't been able to control.I am not pregnant or breastfeeding.I tested positive for hepatitis C but my recent test shows no active virus.I have moderate to severe numbness, tingling, or muscle weakness.You are currently taking any other experimental medications.I have a tumor that can be measured by standard criteria.It's been over 3 weeks or 5 half-lives since my last chemo or biologic therapy.
- Group 1: Treatment (talazoparib, temozolomide)
- 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 the pioneering experiment in its field?
"Talazoparib has been studied for nearly two decades. The first clinical trial started in 2002, sponsored by Schering-Plough and involved 60 patients. Following the completion of Phase 1, Talazoparib was approved for use in phase 2 trials across 45 countries and 1280 cities; at present there are over 260 active studies being conducted with this drug."
What medical conditions can be treated by Talazoparib?
"Aside from being used for nitrosourea treatment, talazoparib can also be taken to address conditions such as refractory advanced mycosis fungoides, advance directives and refractory neuroblastoma."
Could you provide an overview of the prior research conducted pertaining to Talazoparib?
"Currently, Talazoparib is the subject of 261 active research studies with 27 trials in its late-stage. While a majority are situated within Seoul and Songpa, there are 7056 sites currently undertaking clinical tests for this drug."
How many individuals are actively engaged in this clinical experiment?
"Correct. Online records from clinicaltrials.gov indicate that this investigation, which was initially posted on March 23rd 2022 is actively enrolling participants. A total of 34 volunteers are required at two distinct trial sites."
How deleterious is Talazoparib to humans?
"Talazoparib's safety was determined to be a 2 due to the existing evidence from Phase 2 trials, which shows some support for its security but does not confirm any efficacy."
Is enrollment currently available for this research endeavor?
"Affirmative. The information published on clinicaltrials.gov reveals that this medical study, which began recruiting participantson March 23rd 2022, is actively seeking enrollees. The trial requires 34 individuals to be recruited from 2 locations."
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