A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00708292

Purpose

This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.

Condition	Intervention	Phase
Relapsed or Refractory Multiple Myeloma	Drug: AUY922	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multi-Center, Phase I-Ib/II Study of AUY922 Administered as Single Agent and in Combination With Bortezomib With or Without Dexamethasone in Adult Patients in Relapse or Refractory Multiple Myeloma

Further study details as provided by Novartis:

Primary Outcome Measures:

Phase I dose escalation: Maximum tolerated dose Phase Ib dose escalation in combination: Maximum tolerated dose Phase II: Efficacy based on the modified EBT/IMWG response criteria

Secondary Outcome Measures:

Safety assess by the type, frequency and severity of adverse events using CTCAE version 3.0. Pharmacokinetics of AUY922 as a single agent assessed by Cmax, Tmax, t1/2 and AUCt.

Estimated Enrollment:	70
Study Start Date:	July 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Patients must have a diagnosis of active MM according to the International Myeloma Working Group criteria
AUY922 single agent (Phase I & Phase II)
Patients with relapsed-refractory MM who received at least 2 but not more than 3 prior anti-myeloma regimens and had progressed within the last therapy.
Prior therapy must include at least one of the following: bortezomib or lenalidomide or thalidomide.
Induction therapy followed by any kind of stem cell transplantation and/or maintenance therapy is considered as 1 regimen.

Exclusion criteria

Patients with non-secretory MM.
Prior treatment with any HSP90 or HDAC inhibitor for the treatment of MM.
Patients who have received allogenic stem cell transplantation ≥ 12 months prior to enter in the study.
Patients who have received allogenic stem cell transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
Patients with unresolved diarrhea ≥ CTCAE grade 2.
Patients with acute or chronic liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708292

Contacts

Contact: Novartis US	862-778-8300
Contact: Novartis Basel	41 61 324 1111

Locations

United States, Arizona
Mayo Clinic Cancer Center	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Office 507-538-7623
Principal Investigator: K. Stewart, M.D.
United States, Texas
Cancer Therapy & Research Center/UT Health Science Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Imelda Matamoros 210-450-5030 imatamor@idd.org
Principal Investigator: David Halle, M.D.
Germany
Würzburg Uniklinikum	Recruiting
Würzburg, Germany
Contact: Ralf Bargou, M.D. +49-931-201-70280 bargou_r@klinik.uni-wuerzburg.de
Principal Investigator: Rafl Bargou, M.D.
Singapore
Singapore General Hospital	Recruiting
Outram Road, Singapore
Contact: Goh Y Tee, M.D. +65-6321-4855 goh-yeow.tee@sgh.com.sg
Principal Investigator: Goh Y Tee, M.D.
Spain
Hospital la Princesa	Recruiting
Madrid, Spain
Contact: Adrian A Amor, M.D. +34-91-520-23-16 aalegre.hlpr@salud.madrid.org
Principal Investigator: Adrian A Amor, M.D.

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAUY922A2103
Study First Received:	June 27, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00708292
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

AUY922
Multiple Myeloma
HSP90 inhibitors
Phase I/II

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009