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Testing the New Targeted Therapy CYH33 in Combination With the PARP Inhibitor Olaparib in People With Advanced Solid Tumors and DNA Damage Repair Mutations
https://www.facingourrisk.org/research-clinical-trials/study/168/cyh33-in-combination-with-olaparib-in-patients-with-advanced-solid-tumors-and-dna-damage-repair-mutations
Clinicaltrials.gov identifier:
NCT04586335 (https://clinicaltrials.gov/show/NCT04586335)
Treatment
Advanced solid tumors
Study Contact Information:
MD Anderson Cancer Center
Contact: Sandra Montez, RN by phone: 713-745-6274 or by email.
or
Haihe Pharmaceuticals
Jason Sudia, PhD, MPH by email or Frank Tan, MD by email.
About the Study
This study will look at safety and effectiveness of the targeted therapy CYH33 combined with the PARP inhibitor olaparib in people with advanced cancers and a DNA damage repair (DDR) gene mutation whose cancer got worse on, or after receiving a PARP inhibitor. The study will also enroll people with recurrent, platinum resistant ovarian cancer. In addition to safety and efficacy, the study will test whether the combination of CYH33 and olaparib can block tumor growth and overcome a patient’s resistance to PARP inhibitor treatment.
What the Study Entails
- Patients will receive CYH33 once per day orally in combination with 300 mg olaparib two times per day orally.
- Study participants will be followed for 38 months.
Type of Study
- This is an open-label study. All participants will receive both CYH33 and olaparib. The study will enroll several different groups of people based on their tumor type and biomarker or genetic test results.
Study Site
Texas
Houston
MD Anderson Cancer Center
Contact: Sandra Montez, RN by phone: 713-745-6274 or by email.
Principal Investigator: Timothy Yap, MD
This Study is Open To:
People age 18 years or older who meet the following criteria:
- Have advanced recurrent or metastatic (solid tumor) cancer.
- Have progressed after at least one line of previous treatment or for whom there is no standard treatment.
- Have one of the following:
- People with inherited mutations in the following genes may qualify: BRCA1, BRCA2, BLM, FANCA, TP53, RAD51C, and MSH2. People with inherited mutations in other genes may also qualify, contact the study team for more details.
- People with an tumor mutation in one of the genes above or a PIK3CA mutation.
- People with platinum resistant ovarian cancer.
- People with PARP inhibitor resistant ovarian cancer.
This Study is Not Open To:
- Received treatment within the last 28 days or received treatment and have not recovered from its side effects.
- Have diabetes mellitus.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.
