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Protocol Details

An Open-label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0086

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)

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)

None

Intervention(s)

Drug: PT2385

Supporting Site

National Cancer Institute

Background:

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

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ramaprasad Srinivasan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5950
10 CENTER DR
BETHESDA MD 20892
(240) 760-6251
ramasrin@mail.nih.gov

Brooksley Augustine
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3197
brooke.augustine@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03108066

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