This study is NOT currently recruiting participants.
Number
17-C-0086
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Fetuses;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; Von Hippel-Lindau Disease
Investigational Drug(s)
PT2385
Investigational Device(s)
Intervention(s)
Drug: PT2385
Supporting Site
National Cancer Institute
Von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinomas (ccRCC) are kidney tumors. They are associated with a rare genetic disorder. The new drug PT2385 is intended to block a certain protein. Researchers want to see if it can help people with these tumors.
Objectives:
To see how PT2385 affects the tumors in people with VHL Disease-associated ccRCC. To see if there are side effects.
Eligibility:
People age 18 and older who have VHL disease-associated ccRCC tumors.
Design:
Participants will be screened with:
Medical history
Physical exam
Questions about their normal activities like bathing, driving, and working
Heart function test
Blood and urine tests
Eye exam, including pupil dilatation and photos
Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. The IV will be used to give a dye that will travel up to the blood vessels in the eyes.
Tumor scans
Males will have a semen analysis a non-invasive test to measure the testicles
Participants may be asked to provide a new tissue sample.
Participants will have study visits every few weeks for 1 year. Then they will have visits every few months.
Study visits will repeat some of the screening tests. Participants will get a supply of the study drug to take at home. They will take the drug twice a day by mouth.
Participants may have a port device or a catheter inserted to provide blood samples.
Participants will have a final study visit 28 days after they stop the study drug. They may be contacted every 6 months for up to 3 years.
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ELIGIBILITY CRITERIA: -Age greater than or equal to 18 years -ECOG performance status of 0-2 -Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required) -Has a diagnosis of von Hippel-Lindau disease, based on a germline VHL alteration -Has normal organ and marrow function -Able to understand and willing and able to provide informed consent
-Age greater than or equal to 18 years
-ECOG performance status of 0-2
-Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required)
-Has a diagnosis of von Hippel-Lindau disease, based on a germline VHL alteration
-Has normal organ and marrow function
-Able to understand and willing and able to provide informed consent
Principal Investigator
Referral Contact
For more information: