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A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.

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ClinicalTrials.gov Identifier: NCT00708292
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: AUY922 Drug: Bortezomib Drug: Dexamethasone Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2008
Primary Completion Date : January 2011
Study Completion Date : January 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: Single Agent AUY922 Drug: AUY922
Experimental: AUY922 + Bortezomib Drug: AUY922 Drug: Bortezomib
Experimental: AUY922 + Bortezomib + Dexamethasone Drug: AUY922 Drug: Bortezomib Drug: Dexamethasone


Outcome Measures

Primary Outcome Measures :
  1. The safe dose of AUY922 when administered once a week. [ Time Frame: 54 weeks (Maximum Tolerated Dose (MTD)) ]

Secondary Outcome Measures :
  1. The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone. [ Time Frame: 24 weeks (MTD determination of dual and triple combination) ]
  2. Efficacy of AUY922 administered once a week alone and in combination [ Time Frame: at baseline and every 2 cycles (time to document tumor progression) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients must have a diagnosis of active multiple myeloma.
  • Phase I and Phase II part: Patients must have received at least 2 but not more than 4 prior line of therapy and their disease has progressed during or after last therapy.
  • Phase Ib part: Patients must have received no more than 2 prior lines of therapy (excluding dexamethasone as single agent).
  • ECOG Performance Status of ≤ 2.
  • Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
  • Patients must have magnesium levels above lower limit of normal or correctable with supplements.
  • Patients must be willing and able to undergo bone marrow biopsy/aspirate.
  • Able to sign informed consent.

Exclusion criteria:

  • Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple myeloma.
  • Patients with unresolved diarrhea ≥ CTCAE grade 2.
  • Patients with acute or chronic liver disease.
  • Patients using medications that have a relative risk of prolonging the QT interval.
  • Clinically significant cardiac diseases.
  • Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert's syndrome).
  • Pregnant or lactating women.
  • Fertile women of childbearing potential (WCBP) not using adequate contraception.
  • Male patients whose partners are WCBP, not using adequate contraception.
  • Patients who unwilling or unable to comply with the protocol.
  • Phase Ib part: Peripheral neuropathy ≥ CTCAE grade 1.
  • Phase Ib part: Prior treatment with bortezomib.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708292


Locations
United States, Arizona
Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, United States, 85259
United States, Texas
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)
San Antonio, Texas, United States, 78229
Australia
Novartis Investigative Site
Melbourne, Australia, 3004
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Wuerzburg, Germany, 97070
Singapore
Novartis Investigative Site
Singapore, Singapore, 169608
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Madrid, Spain, 28006
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00708292     History of Changes
Other Study ID Numbers: CAUY922A2103
2007-006279-35 ( EudraCT Number )
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: June 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AUY922
Multiple Myeloma
HSP90 inhibitors
Phase I/II

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors