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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00708292




Registration number
NCT00708292
Ethics application status
Date submitted
27/06/2008
Date registered
2/07/2008
Date last updated
22/07/2015

Titles & IDs
Public title
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.
Scientific 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.
Secondary ID [1] 0 0
2007-006279-35
Secondary ID [2] 0 0
CAUY922A2103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AUY922
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: Single Agent AUY922 -

Experimental: AUY922 + Bortezomib -

Experimental: AUY922 + Bortezomib + Dexamethasone -


Treatment: Drugs: AUY922


Treatment: Drugs: Bortezomib


Treatment: Drugs: Dexamethasone


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The safe dose of AUY922 when administered once a week.
Timepoint [1] 0 0
54 weeks (Maximum Tolerated Dose (MTD))
Secondary outcome [1] 0 0
The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.
Timepoint [1] 0 0
24 weeks (MTD determination of dual and triple combination)
Secondary outcome [2] 0 0
Efficacy of AUY922 administered once a week alone and in combination
Timepoint [2] 0 0
at baseline and every 2 cycles (time to document tumor progression)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Germany
State/province [3] 0 0
Frankfurt
Country [4] 0 0
Germany
State/province [4] 0 0
München
Country [5] 0 0
Germany
State/province [5] 0 0
Wuerzburg
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
Spain
State/province [7] 0 0
Catalunya
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00708292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications