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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


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