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Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma

NCT02495103 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-01-26

Study results available
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Summary

Background:

\- There are no established treatments for people with certain advanced kidney cancers. These tumors often don't respond well to currently available treatments. Researchers believe that two drugs that treat other diseases metformin and vandetanib could help people with advanced kidney cancer.

Objective:

\- To test the combination of metformin and vandetanib in people with advanced kidney cancer. Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose in people with certain kidney cancers.

Eligibility:

* For Phase I, people 18 and over with advanced kidney cancer
* For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome

Design:

* The study will last many months.
* Participants will be screened with medical history and physical exam.
* Participants will take the study drugs by mouth every day.
* Participants will measure and record their blood pressure every day.
* Participants will have many tests:
* Blood and urine tests
* Magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET) scan, and other imaging tests: they will lie in machines that take pictures of their body.
* Electrocardiogram (ECG): soft electrodes will be stuck to the skin. A machine will record the hearts signals.
* Bone scan
* Some participants may have a gynecology evaluation or photos of skin tumors taken.
* Participants will have an optional tumor biopsy.
* After they stop taking the drugs, participants may have medical history, physical exam, and blood tests. They will be contacted once a year by phone to find out how they are doing.

Conditions

Interventions

DRUG

Vandetanib

PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.

DRUG

Metformin

Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib

DRUG

Vandetanib/Metformin

Phase II: Vandetanib and metformin by mouth (PO) daily at determined maximum tolerated dose (MTD).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ramaprasad Srinivasan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-26
Primary Completion
2020-02-06
Completion
2020-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495103 on ClinicalTrials.gov