Your session is about to expire
← Back to Search
Olaparib + Temozolomide for Neuroendocrine Cancer
Study Summary
This trial is studying how well adding olaparib to temozolomide works in treating patients with neuroendocrine 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 2016 Phase 2 trial • 175 Patients • NCT01055314Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My bilirubin levels are normal, except for high levels due to Gilbert's syndrome.I have never had myelodysplastic syndrome or acute myeloid leukemia.If you have HIV, your CD4 count must be higher than 250 cells/uL and your HIV viral load must be undetectable within the past 6 months.I have not been treated with temozolomide, dacarbazine, or PARP inhibitors.I do not have severe lung disease affecting both lungs.I do not have any stomach or intestine problems that affect medication absorption.My organs and bone marrow are functioning normally.I can swallow pills without any issues.My cancer can be measured and is at least 1 cm in size, or 1.5 cm if it's in the lymph nodes.My tumor is a confirmed advanced pheochromocytoma or paraganglioma that cannot be surgically removed.I have no allergies to PARP inhibitors or similar drugs.I have not had a bone marrow or cord blood transplant.I am not pregnant or breastfeeding and, if capable of bearing children, I have a recent negative pregnancy test.I will use protection during sex and avoid donating sperm while on the study drug and for 3 months after.I finished any cancer treatments or surgeries at least 28 days ago and have recovered.My heart condition is stable and I don't have long QT syndrome.I finished my antibiotics at least 7 days ago.Your hemoglobin level is at least 10 mg/dL if you have had radionuclide therapy in the past, or at least 8 mg/dL if you have not had this therapy before.My kidney function, measured by creatinine levels or clearance, is within the normal range.I do not have any current infections.My tumor is confirmed to be pheochromocytoma or paraganglioma.My scans show my cancer has grown in the last year.I have stopped taking certain strong medications that affect liver enzymes at least 21 days ago.I am 18 years old or older.I had MIBG therapy over 12 weeks ago and received less than 36 mCi/kg in total.You have enough platelets in your blood (at least 100,000 per cubic millimeter).My cancer has spread and cannot be removed by surgery.You have a high enough number of a type of white blood cell called neutrophils.I am able to get out of my bed or chair and move around.Your total bilirubin level is less than 1.5 times the upper limit of normal.Your AST and ALT levels should not be higher than 3 times the upper limit of normal.I am not currently on combination antiretroviral therapy.
- Group 1: Arm II (temozolomide)
- Group 2: Arm I (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
Is this an innovative research project?
"Temozolomide research has been conducted since 2002, when the drug was sponsored by Schering-Plough. After a successful pilot study with 60 participants that same year, it received Phase 2 approval and is now being researched in 1707 cities across 59 nations - 386 studies are currently active."
Could you elucidate the potential hazards of Temozolomide for patients?
"With Phase 2 clinical trials providing some evidence of safety but no data on efficacy, our team at Power assigned Temozolomide a score of 2."
Have any past experiments incorporated Temozolomide?
"Presently, there are 386 ongoing trials investigating the efficacy of Temozolomide with 51 in late-stage development. Of these clinical sites, Phoenix Arizona holds a substantial number however 13805 other medical centres globally offer this research opportunity."
What is the maximum capacity for recruitment into this trail?
"This medical investigation demands that 76 individuals, who meet the eligibility requirements, enroll. There are several sites allowing patients to join this trial including Memorial Sloan Kettering Basking Ridge in New jersey and Commack in New york."
How many centers are actively administering this research?
"This particular clinical trial is being conducted at a total of 77 medical centres across the US, including but not limited to Memorial Sloan Kettering Basking Ridge in Basking Ridge, Memorial Sloan Kettering Commack in Commack and Memorial Sloan Kettering Bergen in Montvale."
What diseases does Temozolomide typically target?
"Temozolomide is used to treat end-stage conditions such as relapse following chemo, progression of illness, and exposure to nitrosoureas."
Is the recruitment phase of this research project still underway?
"That is correct - as of 11/2/2022, clinicaltrials.gov states that this medical research project is actively recruiting for 76 participants across 77 sites. The trial was initially posted on November 2nd 2020."
Share this study with friends
Copy Link
Messenger