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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02939183




Registration number
NCT02939183
Ethics application status
Date submitted
18/10/2016
Date registered
19/10/2016

Titles & IDs
Public title
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Scientific title
(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
20160104
Universal Trial Number (UTN)
Trial acronym
INTREPID-1
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 - Immediate Release (IR) Formulation
Treatment: Drugs - Gastro-Retentive (GR) Formulation
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Pomalidomide

Experimental: Part 1 Arm 1 - Oprozomib (Immediate Release) plus dexamethasone

Experimental: Part 1 Arm 2 - Oprozomib (Gastro-retentive) plus dexamethasone

Experimental: Part 2 Arm 1 - Oprozomib (Immediate release) plus pomalidomide and dexamethasone

Experimental: Part 2 Arm 2 - Oprozomib (Gastro-retentive) plus pomalidomide and dexamethasone


Treatment: Drugs: Immediate Release (IR) Formulation
Immediate Release (IR) Formulation

Treatment: Drugs: Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation

Treatment: Drugs: Dexamethasone
Dexamethasone

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

Outcomes
Primary outcome [1] 0 0
Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone
Timepoint [1] 0 0
The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Primary outcome [2] 0 0
Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment
Timepoint [2] 0 0
Data collected up to 2 months from the date of last subject enrollment.
Primary outcome [3] 0 0
Incidence of treatment-emergent adverse events
Timepoint [3] 0 0
Data collected up to 2 months from the date of last subject enrollment.
Primary outcome [4] 0 0
Number of patients with changes in laboratory test results
Timepoint [4] 0 0
The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax)
Timepoint [1] 0 0
At the highest concentration of drug in the blood.
Secondary outcome [2] 0 0
Time to Cmax (tmax)
Timepoint [2] 0 0
time to achieve Cmax.
Secondary outcome [3] 0 0
Area under the concentration-time curve
Timepoint [3] 0 0
time 0 to the time of last quantifiable concentration (AUClast)
Secondary outcome [4] 0 0
Overall response
Timepoint [4] 0 0
All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Secondary outcome [5] 0 0
Best overall response
Timepoint [5] 0 0
All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Secondary outcome [6] 0 0
Progression free survival
Timepoint [6] 0 0
4 months
Secondary outcome [7] 0 0
Duration of response
Timepoint [7] 0 0
4 months

Eligibility
Key inclusion criteria
Inclusion criteria

* Participant must have a pathologically documented, definitively diagnosed, multiple myeloma relapse, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide.
* Participant must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
* Measurable disease (assessed within 28 days prior to day 1).
* Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
* Other Inclusion Criteria May Apply
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s).
* Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1; received immunosuppressive therapy within the last 3 months prior to study day 1; having signs or symptoms of acute or chronic graft-versus-host disease.
* Autologous stem cell transplant < 90 days prior to study day 1.
* Multiple myeloma with IgM subtype.
* POEM syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
* Plasma cell leukemia (> 2.0 X10^9/L circulating plasma cells by standard differential).
* Waldenstrom's macroglobulinemia.
* Other 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
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
17/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2022
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Murdoch
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Spain
State/province [17] 0 0
Castilla León
Country [18] 0 0
Spain
State/province [18] 0 0
Navarra

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02939183