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Temozolomide + Olaparib for Colorectal Cancer
Study Summary
This trial is testing a combination of two drugs to treat patients with a specific type of advanced colorectal cancer.
- Colorectal Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 11 Patients • NCT04166435Trial Design
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- You have been diagnosed with advanced colorectal cancer that has not responded to previous treatments and has specific genetic characteristics.You are allergic to temozolomide or olaparib or any of their ingredients.You are allergic to the medication being used in the clinical trial.If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patientIndividuals who are not currently experiencing any health problems and who have passed a medical evaluation including a medical history, physical examination, laboratory tests, and cardiac monitoring.Haemoglobin levels of 10.0 g/dL or more, without any blood transfusions in the past 28 days.A person is capable of giving their consent if they can understand the information given to them, including the risks and benefits of participating in the study, and they can make a decision on whether or not to participateYou are currently breastfeeding a baby.The participant will be given a written informed consent form to sign before any study specific procedures, sampling, or analyses are conducted.DNA from research participants is now required by many institutions, but a recent study showed that almost half the subjects who provided consent did not understand the nature of the consent form they had signedThe MGMT gene promoter is hypermethylated on pre-screening in a significant percentage of tumors.with ANC decline of ≥30% from baseline over any 7 day period ANC decline ≥ 30% from nadir
Absolute neutrophil count (ANC) ≥ 1.You have already tried at least two different types of standard treatment for your advanced cancer and it did not work or you could not tolerate it. If you have used all chemotherapy drugs together before, one prior treatment is acceptable after talking with the main doctor. If your cancer came back within six months of finishing your first treatment, it counts as one line of treatment.You have had cancer in the past, but it must have been treated successfully without any signs of the disease for at least 5 years. Exceptions are made for certain types of cancer that were treated successfully, such as skin or cervical cancer.
- Group 1: Temozolomide + Olaparib
- 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
What past experiments have combined Temozolomide with Olaparib to observe their effects?
"Currently, there are 386 registered studies that involve Temozolomide and Olaparib, with 51 of them in the third phase. Phoenix, Arizona houses several investigations related to this medication combination while 13805 other sites conduct trials for it."
Has any similar research been conducted in the past?
"Temozolomide + Olaparib has been studied since the early 2000s, beginning with a Phase 1 trial sponsored by Schering-Plough in 2002. After 60 patients were tested and results showed efficacy, this drug combo was approved for further clinical trials. Currently there are 386 active experiments spanning 59 countries across 1707 cities that involve Temozolomide + Olaparib."
Is there any way to become involved in this clinical research at the present time?
"Unfortunately, this research is not presently enrolling participants. It was originally listed on June 17th 2020 and last modified on August 17th 2022. If you are seeking alternative studies, there are 1064 trials for colorectal cancer currently recruiting patients as well as 386 clinical investigations that involve the combination of Temozolomide + Olaparib treatment options."
How many research participants comprise the sample size of this study?
"Unfortunately, this trial is not accepting volunteers at the current time. It was published on June 17th 2020 and last updated August 17th 2022; however, there are currently 1,064 clinical trials recruiting patients with colorectal cancer and 386 studies actively seeking participants for Temozolomide + Olaparib therapy."
Has the combination of Temozolomide and Olaparib been accepted by the FDA?
"Our experts at Power reckoned the safety of Temozolomide + Olaparib a 2 on our scale since this is a Phase 2 clinical trial, which implies some data attesting to its security but none that can corroborate efficacy."
What medical indications are typically treated with Temozolomide + Olaparib?
"Temozolomide + Olaparib can be an effective therapeutic option for patients with pre-existing advance directives, those who have undergone prior chemotherapy treatments and individuals whose disease has progressed."
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