Selumetinib + Olaparib for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for some drugs. If you are taking strong or moderate CYP3A inducers or inhibitors, you will need to stop them for a few weeks before starting the trial. Check with the study team to see if your specific medications are affected.
What data supports the effectiveness of the drug Olaparib in cancer treatment?
Is the combination of Selumetinib and Olaparib safe for humans?
Olaparib (also known as Lynparza) has been tested in various studies and is generally considered safe for humans, with research showing its safety in patients with advanced solid tumors. However, specific safety data for the combination of Selumetinib and Olaparib is not provided in the available research.35678
What makes the drug combination of Selumetinib and Olaparib unique for cancer treatment?
The combination of Selumetinib and Olaparib is unique because it targets cancer through two different mechanisms: Selumetinib inhibits MEK1/2, a protein involved in cell growth, while Olaparib inhibits PARP, a protein involved in DNA repair. This dual approach may offer a novel way to treat cancers that are resistant to other therapies.3591011
What is the purpose of this trial?
This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion).The goal of Phase 1 of this clinical research study is to find the highest tolerable dose combination of selumetinib and olaparib that can be given to patients who have solid tumors that are advanced or recurrent (has returned after treatment).The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1 can help to control advanced or recurrent solid tumors.The safety of the study drug combination will also be studied in both parts.This is an investigational study. Selumetinib is not FDA approved or commercially available. It is currently being used for research purposes only. Olaparib is FDA approved and commercially available for the treatment of ovarian cancer that has a certain type of genetic mutation (change). It is considered investigational to use selumetinib in combination with olaparib to treat advanced or recurrent cancer.The study doctor can explain how the study drugs are designed to work. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.
Research Team
Shannon Westin, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adults with advanced or recurrent solid tumors, including various cancers like breast, thyroid, and cervical cancer. Participants must have a life expectancy of at least 16 weeks and be able to follow the study protocol. Women should not be pregnant or breastfeeding and must use effective contraception; men also need to use condoms. Patients should have adequate organ function and may have had any number of prior chemotherapy treatments but must be recovered from major surgeries or previous treatment side effects.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase 1)
Participants receive increasing doses of selumetinib and olaparib to determine the maximum tolerated dose
Dose Expansion (Phase 2)
Participants receive the maximum tolerated dose of selumetinib and olaparib to evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olaparib
- Selumetinib
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology