drugset / Trial / NCT02192541

Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas

NCT02192541

Phase 1 Terminated 5 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Background: \- Some people have cancers that don't respond to standard treatments. In these cases, doctors may try to use drugs to slow the growth of the cancer. Objectives: \- To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept. Eligibility: \- Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and sarcomas. Design: * Participants will be screened with medical history, blood tests, and scans to measure their tumors. * Participants will have one or two eye exams, with dilating eye drops. * Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib will be given once a week on the same day for 3 weeks in a row, followed by a 1-week rest period. Ziv-aflibercept will be given once every other week. The drugs will be given in 28-day cycles. * Participants may have a small piece of their tumor collected once or twice. This is done using a small needle during computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound scan. * Participants will have their blood pressure checked at each visit. They will check it at home every day of the study. * Participants may have one or more whole-body positron emission tomography (PET) scans with 89Zr-panitumumab. A small amount of a radioactive chemical will be injected through a tube in an arm. Participants will lie on a bed that slides in and out of the donut-shaped PET scanner. They will have small amounts of blood drawn. * Participants may stay in the study as long as they are tolerating the drugs and their tumor is not getting worse.

Timeline

Start
2014-12-02
Primary completion
2016-02-25
Completion
2016-02-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 3 mg/kg Intravenous
Subject Aflibercept Protein / enzyme biologic 4 mg/kg Intravenous
Subject Ganetespib Small molecule 100 mg/m2 Intravenous

Indications