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Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer

NCT01554969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-02-22

No results posted yet for this study

Summary

The purpose of this study is to find out what effects, good and/or bad, the combination of the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine, radiation, and the study drug kill cancer cells in different ways. Giving these treatments together may make your cancer shrink or slow down its growth more than it would if you got treated with capecitabine and radiation alone.

This is a Phase I drug study of ganetespib given together with capecitabine and radiation in patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not approved by the Food and Drug Administration (FDA). The other two, capecitabine and radiation, are approved by FDA for use in rectal cancer.

In this study, the investigators will test different dosages of the "investigational" (experimental) drug, called ganetespib (the study drug). The study drug is "investigational" because it is not approved by the FDA for use. The study drug has been previously tested in humans. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. In addition, the study will help researchers to determine what the side effects and drug interactions might be.

The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and capecitabine with radiation work in your body (for example how long the drugs last in your body.)

Conditions

Interventions

DRUG

capecitabine + ganetespib

Capecitabine will be started on Day 1 of the concurrent chemo-radiation phase at the specified dose, and is given orally twice daily for the entire duration of radiation therapy. Ganetespib will be started on Day 1 of radiation therapy and is administered as IV infusion over 1 hour on days 1, 8, 15 for cycle 1 and then on days 29 and 36 for cycle 2. In all patients, ganetespib monotherapy will be given up to 2 weeks prior to start of concurrent chemoradiation. Sequential biopsies will be taken at baseline and prior to the start of concurrent chemoradiation. In the dose escalation part of the study, the starting does of ganetespib is 60mg/m² once weekly, and capecitabine at a dose of 825 mg/m² twice daily.

Sponsors & Collaborators

  • Synta Pharmaceuticals Corp.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Bassel El-Rayes, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-03-31
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01554969 on ClinicalTrials.gov