Study Complete
Sponsor ID
20160104

Phase 1b study evaluating OPomD in relapsed or refractory multiple myelomaINTREPID-1

Sponsor ID
20160104
Clinicaltrials.gov ID
NCT02939183
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Additional Study Details

Phase
Phase 1
Product
oprozomib
Type
Interventional
Masking
None (Open Label)
Enrollment
61
Additional Study Details

Protocol Summary

Primary Outcome Measures

Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone

Timeframe: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment

Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment

Timeframe: Data collected up to 2 months from the date of last subject enrollment.

Incidence of treatment-emergent adverse events

Timeframe: Data collected up to 2 months from the date of last subject enrollment.

Number of patients with changes in laboratory test results

Timeframe: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment

Secondary Outcome Measures

Maximum observed concentration (Cmax)

Timeframe: At the highest concentration of drug in the blood.

Time to Cmax (tmax)

Timeframe: time to achieve Cmax.

Area under the concentration-time curve

Timeframe: time 0 to the time of last quantifiable concentration (AUClast)

Overall response

Timeframe: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).

Best overall response

Timeframe: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).

Progression free survival

Timeframe: 4 months

Duration of response

Timeframe: 4 months

Locations

Location
Status
Contact Us
Location
Research Site
West Hollywood, CA, United States, 90069
Status
Recruiting
Location
Research Site
Milwaukee, WI, United States, 53226
Status
Recruiting
Location
Research Site
Murdoch, WA, Australia, 6150
Status
Recruiting
Location
Research Site
St. Louis, MO, United States, 63110
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30322
Status
Recruiting
Location
Research Site
Chicago, IL, United States, 60637-6613
Status
Recruiting
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