Protocol Details
An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma.
This study is NOT currently recruiting participants.
Summary
Number |
18-C-0138 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Fetuses;
Pregnant Women;
Children |
Keywords |
Hereditary Cancer Disease;
Germline VHL Alteration;
Small Molecule Inhibitor of HIF-2a |
Recruitment Keyword(s) |
None |
Condition(s) |
Clear Cell Renal Cell Carcinoma |
Investigational Drug(s) |
PT2977
|
Investigational Device(s) |
None |
Intervention(s) |
Drug: PT2977
|
Supporting Site |
National Cancer Institute |
Background:
Von Hippel-Lindau (VHL) disease-associated renal cell carcinomas are kidney tumors. They are associated with a rare genetic disorder. The drug PT2977 (belzutifan) blocks the action of a certain protein that is often overactive in these types of tumors. Researchers think the drug might help treat people with these tumors.
Objective:
To test how PT2977 (belzutifan) affects tumors in people with VHL disease-associated kidney cancer. To see if the drug has side effects.
Eligibility:
People ages 18 and older with VHL disease-associated kidney cancer
Design:
Participants will be screened with:
Medical and medication history
Physical exam
Questions about how well they are able to do normal activities
Biopsy results and tissue sample. If they do not have a sample, participants may need to have a new biopsy.
Heart and blood tests
Eye exam
Semen samples for male participants
CT scan, MRI, or ultrasound: Participants will lie on a table. A machine will take pictures of the body.
Participants will have visits every other week for the first 5 weeks, then every 4 weeks for the next 5 visits, and then every 12 weeks. Visits include repeats of screening tests.
Participants will receive a supply of the study drug at each visit to take at home. They will take 3 tablets by mouth daily.
Participants will continue treatment until they can no longer tolerate it or their disease gets worse.
Participants will have a final study visit 28 days after they take their last dose of study drug. This will include repeats of screening tests.
Participants may be contacted every 6 months for a period of up to 3 years after the study.
Eligibility
Eligibility:
-18 years of age or older with ability to understand and willingness to sign a written informed consent
-Diagnosis of von Hippel-Lindau disease, based on a germline VHL alteration
-At least 1 measurable solid RCC tumor and no RCC tumor greater than 3.0 cm that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Patients may have VHL disease-associated tumors in other organ systems.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03401788