Waldenstrom's Macroglobulinemia
Conditions
Brief summary
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Detailed description
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
Interventions
DRUGIMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
Sponsors
Idera Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed 24 weeks of treatment in Protocol 8400-401
Exclusion criteria
* Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401. * Has evidence of disease progression under Protocol 8400-401. * Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | During receipt of study treatment on the trial. | Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 twice weekly per Protocol 8400-401 | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 4 |
Baseline characteristics
| Characteristic | IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk |
|---|---|
| Age, Continuous | 65 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants With Adverse Events
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Time frame: During receipt of study treatment on the trial.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Number of Participants With Adverse Events | 4 Participants |