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.
NCT ID: NCT00708292
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2008-07-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single Agent AUY922
AUY922
AUY922 + Bortezomib
AUY922
Bortezomib
AUY922 + Bortezomib + Dexamethasone
AUY922
Bortezomib
Dexamethasone
Interventions
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AUY922
Bortezomib
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)
San Antonio, Texas, United States
Novartis Investigative Site
Melbourne, , Australia
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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References
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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.
Related Links
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Results for CAUY922A2103 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2007-006279-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAUY922A2103
Identifier Type: -
Identifier Source: org_study_id
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