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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02939183
Ethics application status
Date submitted
18/10/2016
Date registered
19/10/2016
Date last updated
24/12/2019

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

- Subject must have a pathologically documented, definitively diagnosed, multiple
myeloma relapsed, 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.

- Subject 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
Gender
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.

- POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).

- Plasma cell leukemia (> 2.0 X109/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
Active, not recruiting
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)
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
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in
patients with relapsed refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/show/NCT02939183
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

Summary results
Other publications