Trial Outcomes & Findings for Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation (NCT NCT02252146)
NCT ID: NCT02252146
Last Updated: 2017-12-12
Results Overview
Frequency of adverse events, injection site reactions, and concomitant medications observed
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 2 years from first patient visit
Results posted on
2017-12-12
Participant Flow
Participant milestones
| Measure |
IMO-8400
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: IMO-8400 given subcutaneously twice weekly
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
IMO-8400
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: IMO-8400 given subcutaneously twice weekly
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Entered hospice care
|
1
|
|
Overall Study
Inability to travel to study site
|
1
|
Baseline Characteristics
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Baseline characteristics by cohort
| Measure |
IMO-8400
n=6 Participants
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: MO-8400 given subcutaneously twice weekly
|
|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years from first patient visitPopulation: Safety population
Frequency of adverse events, injection site reactions, and concomitant medications observed
Outcome measures
| Measure |
IMO-8400
n=6 Participants
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: MO-8400 given subcutaneously twice weekly
|
|---|---|
|
Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Subjects with TEAEs
|
4 Participants
|
|
Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Subjects with ISRs
|
1 Participants
|
|
Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Subjects with Concomitant Medications
|
3 Participants
|
Adverse Events
IMO-8400
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
IMO-8400
n=6 participants at risk
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: MO-8400 given subcutaneously twice weekly
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
General disorders
Disease progression
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
Other adverse events
| Measure |
IMO-8400
n=6 participants at risk
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
IMO-8400: MO-8400 given subcutaneously twice weekly
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Eye disorders
Lacrimation increase
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Eye disorders
Eye discharge
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Up to 2 years after start of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
General disorders
Disease progression
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Investigations
Hyperkalaemia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Investigations
Hyponatraemia
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
33.3%
2/6 • Up to 2 years after start of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
|
Skin and subcutaneous tissue disorders
Hypotension
|
16.7%
1/6 • Up to 2 years after start of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place