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.
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.
2 other identifiers
interventional
29
5 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2008
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedDecember 17, 2020
June 1, 2015
2.5 years
June 27, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safe dose of AUY922 when administered once a week.
54 weeks (Maximum Tolerated Dose (MTD))
Secondary Outcomes (2)
The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.
24 weeks (MTD determination of dual and triple combination)
Efficacy of AUY922 administered once a week alone and in combination
at baseline and every 2 cycles (time to document tumor progression)
Study Arms (3)
Single Agent AUY922
EXPERIMENTALAUY922 + Bortezomib
EXPERIMENTALAUY922 + Bortezomib + Dexamethasone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, 85259, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Melbourne, 3004, Australia
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
Würzburg, 97070, Germany
Novartis Investigative Site
Singapore, 169608, Singapore
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Madrid, 28006, Spain
Related Publications (1)
Seggewiss-Bernhardt R, Bargou RC, Goh YT, Stewart AK, Spencer A, Alegre A, Blade J, Ottmann OG, Fernandez-Ibarra C, Lu H, Pain S, Akimov M, Iyer SP. Phase 1/1B trial of the heat shock protein 90 inhibitor NVP-AUY922 as monotherapy or in combination with bortezomib in patients with relapsed or refractory multiple myeloma. Cancer. 2015 Jul 1;121(13):2185-92. doi: 10.1002/cncr.29339. Epub 2015 Mar 24.
PMID: 25809731DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
December 17, 2020
Record last verified: 2015-06