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Sequential Olaparib + Adavosertib for Cancer
Study Summary
This trial is testing adavosertib with olaparib to see if it's effective at treating patients with solid tumors that have spread with selected mutations.
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.Trial Design
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- My liver and kidney function tests are within acceptable ranges.I am fully active or can carry out light work.I have or had myelodysplastic syndrome or acute myeloid leukemia.I have a genetic mutation in BRCA1 or BRCA2.I will use a condom during treatment and for 3 months after, and my female partner will use effective birth control.My cancer initially responded to treatment but has since gotten worse.I have BRCA mutations and my cancer progressed after PARP inhibitor treatment.I finished palliative radiation at least 14 days ago and have recovered from immediate side effects.I am not taking strong or moderate drugs that affect liver enzymes.I have specific gene mutations related to DNA repair or cyclin E amplification.I am 18 years old or older.You are pregnant or currently nursing a baby.I had Torsades de pointes but all risk factors have been corrected.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.My tumor can be measured and biopsied, and I agree to have a biopsy.My cancer has spread, cannot be surgically removed, and standard treatments are not effective.I have brain metastases or leptomeningeal disease but don't need immediate brain treatment.I am allergic to medications similar to AZD1775 or olaparib.I am not taking any other cancer treatments while on the study medication.I've had at least one treatment for my advanced cancer or there are no treatments known to work for me.I had treatment with PARP inhibitors, showed improvement but then my cancer progressed. I also have specific genetic mutations or changes.I am using two effective birth control methods or not having sex.I am HIV-positive, on treatment, with no recent severe infections and a good immune status.I have brain metastases but they are stable and treated.I have lasting side effects from cancer treatment, but not hair loss.I haven't had serious heart issues like heart attacks or uncontrolled heart rhythm problems in the last 6 months.I've had at least one treatment for my advanced cancer or there are no known treatments for it.My cancer can be measured and biopsied safely, and I agree to have a biopsy.My cancer has spread, cannot be surgically removed, and standard treatments are not effective.I have not had radiotherapy in the last 28 days.I have been treated with PARP inhibitors before.I am willing and able to follow the study's requirements.I finished any palliative radiation therapy over 2 weeks ago and have recovered from its side effects.My brain cancer has not worsened in the last 28 days.I haven't taken any cancer drugs in the last 28 days or 5 half-lives.I cannot swallow pills or have a stomach condition that affects medication absorption.I have had a bone marrow or cord blood transplant before.I will not drink grapefruit juice while taking the study drugs.
- Group 1: Treatment (olaparib, adavosertib)
- 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
Has the regulatory body accepted olaparib and adavosertib as viable treatments?
"Due to limited safety and efficacy data, Treatment (olaparib, adavosertib) is assigned a score of 1 out of 3 by Power's personnel. This indicates that it is in the early stages of evaluation as part of Phase 1 trials."
What indications do olaparib and adavosertib commonly treat?
"Olaparib and adavosertib can be taken to treat a variety of conditions, such as advanced directives, malignant neoplasm in the ovary, primary pericardial cancer, perceptual anomalies, and somatic symptoms."
Is there an ongoing enrollment process for this research?
"Unfortunately, this clinical trial is not presently seeking out recruits. Initially posted on April 15th 2020 and most recently edited on March 7th 2023, the study has yet to start accepting patients. Nonetheless, there are still 2,624 other trials currently enrolling candidates."
How many participants are enrolled in the current research project?
"Currently, this trial is no longer accepting participants. The first post was on April 15th of 2020 and the last edit occured on March 7th of 2023. For other studies related to brain metastasis, 2435 trials are actively enrolling patients while 189 others are specifically researching olaparib and adavosertib treatments."
What research has been conducted thus far concerning the use of olaparib and adavosertib to treat patients?
"At the present moment, there are 189 studies into Treatment (olaparib, adavosertib) with 25 of these trials in Phase 3. While Houston, Texas is home to most of them, 10372 other medical centres worldwide are participating in research surrounding this particular treatment."
What ultimate goal is this trial attempting to achieve?
"This medical study, which is slated to last up to 28 days, will measure the incidence of adverse events as its primary objective. Secondary objectives include estimating overall response rate (ORR) with 95% confidence intervals and utilising Kaplan-Meier method for measuring overall survival rate. Additionally, it aims to understand how olaparib and adavosertib interact in relation to putative predictive biomarkers of resistance or response."
Is this an inaugural investigation of its kind?
"As of now, 189 clinical trials for Treatment (olaparib, adavosertib) are ongoing in 1632 cities and 61 nations. The inaugural trial for this treatment was established by AstraZeneca back in 2005. Initially enrolling 98 participants, the Phase 1 process has since been completed 93 times over."
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