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A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma

NCT01485835 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-10-12

No results posted yet for this study

Summary

The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. The investigators will also determine the side effects of ganetespib at different dose levels when given in combination with bortezomib and the effect the combination has on your cancer. The study will measure levels of the drug in your blood and bone marrow as well.

Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is Velcade®.

Ganetespib is considered "investigational" because it has not received approval from the Food and Drug Administration for general use, although it has been previously tested in humans.

Conditions

Interventions

DRUG

Ganetespib

Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.

DRUG

Bortezomib

Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.

DRUG

Dexamethasone

Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.

Sponsors & Collaborators

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • Synta Pharmaceuticals Corp.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Sagar Lonial, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT01485835 on ClinicalTrials.gov