8400-401: Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Sponsor
Idera Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02092909
Collaborator
(none)
31
10
1
44.1
3.1
0.1
Study Details
Study Description
Brief Summary
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Eligible subjects will be enrolled and assigned to escalating dose cohorts. Treatment will be administered by subcutaneous injection.
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Study Start Date
:
Mar 1, 2014
Actual Primary Completion Date
:
Apr 1, 2017
Actual Study Completion Date
:
Nov 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMO-8400 at escalating dose levels IMO-8400 at escalating dose levels by subcutaneous injection |
Drug: IMO-8400
IMO-8400 at escalating dose levels by subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia [Up to 24 weeks]
Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events
Secondary Outcome Measures
- Best Overall Response [Up to 24 weeks]
Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia
- Identify the Number of Patients Experiencing DLTs at Each Dose Level [28 days]
To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level
- Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax. [Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)]
Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax.
- Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - AUC0-t (hr*ng/mL) [Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)]
Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - AUC0-t (hr*ng/mL) .
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patients must have a diagnosis of relapsed Waldenstrom's Macroglobulinemia.
In addition to the above, key inclusion and exclusion criteria are listed below.
Inclusion Criteria:
-
At least 18 years of age.
-
Agree to use contraception
-
Hemoglobin ≥ 7.5 g/dL, - Absolute neutrophil count ≥ 1.0 x 109/L (1000/mm3), - Platelets ≥ 50,000/μL
Exclusion Criteria:
-
Is nursing or pregnant
-
Has BMI > 34.9 kg/m2.
-
Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg).
-
Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily.
-
Being treated with other anti-cancer therapies (approved or investigational).
-
Has, at the initiation of study drug, received cytotoxic chemotherapy or a Bruton's tyrosine kinase (BTK)-inhibitor (e.g. ibrutinib) within the past 3 weeks or rituximab within the past 2 months
-
Has an active infection requiring systemic antibiotics.
-
Has had surgery requiring general anesthesia within 4 weeks of starting the study.
-
Has autoimmune cytopenia (anemia, thrombocytopenia, leukopenia).
-
Has heart failure of Class III or IV.
-
Has sensory or motor neuropathy limiting daily activities.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Centers of Excellence | Fayetteville | Arkansas | United States | 72758 |
| 2 | UCLA | Los Angeles | California | United States | 90404 |
| 3 | Mayo Clinic Jacksonville | Jacksonville | Florida | United States | 32224 |
| 4 | Emory Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 5 | Horizon BioAdvance | Lafayette | Indiana | United States | 47905 |
| 6 | Mayo Clinic | Rochester | Minnesota | United States | 55902 |
| 7 | Hackensack University | Hackensack | New Jersey | United States | 07601 |
| 8 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 9 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 10 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Idera Pharmaceuticals, Inc.
Investigators
- Study Director: Mark Cornfeld, MD, MPH, Idera Pharmaceuticals, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02092909
Other Study ID Numbers:
- 8400-401
First Posted:
Mar 20, 2014
Last Update Posted:
Sep 10, 2019
Last Verified:
Aug 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were enrolled from 02 April 2014 through 31 March 2017 at 14 study sites in the United States. |
|---|---|
| Pre-assignment Detail | Screening occurred ≤ 21 days before Day 1 (the first injection of study drug). |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Period Title: Overall Study | ||||
| STARTED | 6 | 5 | 14 | 6 |
| COMPLETED | 5 | 2 | 5 | 0 |
| NOT COMPLETED | 1 | 3 | 9 | 6 |
Baseline Characteristics
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk | Total |
|---|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. | Total of all reporting groups |
| Overall Participants | 6 | 5 | 14 | 6 | 31 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
74.8
(12.92)
|
70.4
(9.71)
|
66.5
(11.17)
|
62.7
(11.36)
|
68.0
(11.53)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
2
33.3%
|
3
60%
|
3
21.4%
|
1
16.7%
|
9
29%
|
| Male |
4
66.7%
|
2
40%
|
11
78.6%
|
5
83.3%
|
22
71%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
6
100%
|
5
100%
|
14
100%
|
6
100%
|
31
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
1
7.1%
|
1
16.7%
|
2
6.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
7.1%
|
0
0%
|
1
3.2%
|
| White |
6
100%
|
5
100%
|
12
85.7%
|
5
83.3%
|
28
90.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
6
100%
|
5
100%
|
14
100%
|
6
100%
|
31
100%
|
| Time Since WM Diagnosis (yrs) (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
7.03
(4.62)
|
10.16
(6.90)
|
7.66
(3.55)
|
5.78
(5.22)
|
7.58
(4.66)
|
| Baseline IPSSWM Score (Count of Participants) | |||||
| Low |
2
33.3%
|
1
20%
|
5
35.7%
|
2
33.3%
|
10
32.3%
|
| Intermediate |
3
50%
|
3
60%
|
8
57.1%
|
4
66.7%
|
18
58.1%
|
| High |
1
16.7%
|
1
20%
|
1
7.1%
|
0
0%
|
3
9.7%
|
| Baseline Total IgM (mg/dL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mg/dL] |
1090
(NA)
|
2410
(973)
|
2857
(1567)
|
2910
(1727)
|
2715
(1473)
|
| Baseline Monoclonal IgM (g/dL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [g/dL] |
1.04
(0.640)
|
0.93
(0.614)
|
1.57
(0.835)
|
1.62
(0.741)
|
1.37
(0.773)
|
Outcome Measures
| Title | Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia |
|---|---|
| Description | Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events |
| Time Frame | Up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Measure Participants | 6 | 5 | 14 | 6 |
| At Least 1 TEAE |
6
100%
|
5
100%
|
14
100%
|
6
100%
|
| At Least 1 Related TEAE |
5
83.3%
|
2
40%
|
12
85.7%
|
6
100%
|
| At Least 1 Grade >=3 TEAE |
1
16.7%
|
2
40%
|
7
50%
|
3
50%
|
| At Least 1 SAE |
0
0%
|
0
0%
|
1
7.1%
|
2
33.3%
|
| At Least 1 DLT |
0
0%
|
0
0%
|
1
7.1%
|
0
0%
|
| At Least 1 TEAE Leading to Death |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| At Least 1 TEAE Leading to Premature Treatment DC |
0
0%
|
0
0%
|
4
28.6%
|
2
33.3%
|
| Title | Best Overall Response |
|---|---|
| Description | Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia |
| Time Frame | Up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Population |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Measure Participants | 5 | 4 | 12 | 5 |
| Complete Response |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Very Good Partial Response |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Partial Response |
1
16.7%
|
0
0%
|
2
14.3%
|
0
0%
|
| Minor Response |
2
33.3%
|
0
0%
|
4
28.6%
|
1
16.7%
|
| Standard Deviation |
2
33.3%
|
3
60%
|
4
28.6%
|
3
50%
|
| Progressive Disease |
0
0%
|
1
20%
|
1
7.1%
|
1
16.7%
|
| Not Evaluable |
0
0%
|
0
0%
|
1
7.1%
|
0
0%
|
| Title | Identify the Number of Patients Experiencing DLTs at Each Dose Level |
|---|---|
| Description | To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Measure Participants | 6 | 5 | 14 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
1
7.1%
|
0
0%
|
| Title | Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax. |
|---|---|
| Description | Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax. |
| Time Frame | Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Population |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Measure Participants | 6 | 5 | 14 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [Cmax (ng/mL)] |
807.6
(70.3)
|
2137.9
(68.7)
|
2421.2
(50.8)
|
4433.1
(29.9)
|
| Title | Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - AUC0-t (hr*ng/mL) |
|---|---|
| Description | Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - AUC0-t (hr*ng/mL) . |
| Time Frame | Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk |
|---|---|---|---|---|
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. |
| Measure Participants | 6 | 5 | 14 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [AUC0-t (hr*ng/mL)] |
2565.8
(64.6)
|
6493.0
(61.7)
|
7229.3
(54.5)
|
13691.7
(32.3)
|
Adverse Events
| Time Frame | From obtaining informed consent through EOS visit. (up to 24 weeks) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk | ||||
| Arm/Group Description | IMO-8400 0.6 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg once weekly s.c. | IMO-8400 1.2 mg/kg twice weekly s.c. | IMO-8400 2.4 mg/kg once weekly s.c. | ||||
All Cause Mortality |
||||||||
| IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
Serious Adverse Events |
||||||||
| IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 2/6 (33.3%) | ||||
| Infections and infestations | ||||||||
| Sepsis | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Lower limb fracture | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthritis | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 |
| Arthralgia | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary embolism | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| IMO-8400 0.6 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 1x/wk | IMO-8400 1.2 mg/kg 2x/wk | IMO-8400 2.4 mg/kg 1x/wk | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 5/5 (100%) | 13/14 (92.9%) | 6/6 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anemia | 0/6 (0%) | 1/5 (20%) | 5/14 (35.7%) | 0/6 (0%) | ||||
| Lymph node pain | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Neutropenia | 1/6 (16.7%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Splenomegaly | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Thrombocytopenia | 0/6 (0%) | 1/5 (20%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Cardiac disorders | ||||||||
| Tachycardia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Ear and labyrinth disorders | ||||||||
| Tinnitus | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Eye disorders | ||||||||
| Diplopia | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Dry eye | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Eye pruritis | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Lacrimation increased | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Vision blurred | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Abdominal distension | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Abdominal pain | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Constipation | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 2/6 (33.3%) | ||||
| Diarrhoea | 0/6 (0%) | 0/5 (0%) | 3/14 (21.4%) | 3/6 (50%) | ||||
| Dry mouth | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Dyspepsia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Early satiety | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Gastrointestinal pain | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Haematochezia | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Impaired gastric emptying | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Nausea | 1/6 (16.7%) | 1/5 (20%) | 3/14 (21.4%) | 3/6 (50%) | ||||
| Stomatitis | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Vomiting | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 2/6 (33.3%) | ||||
| General disorders | ||||||||
| Chills | 0/6 (0%) | 1/5 (20%) | 2/14 (14.3%) | 2/6 (33.3%) | ||||
| Fatigue | 1/6 (16.7%) | 1/5 (20%) | 5/14 (35.7%) | 3/6 (50%) | ||||
| Hyperhidrosis | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Influenza like illness | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Infusion related reaction | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Injection site bruising | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Injection site erythema | 3/6 (50%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Injection site haemorrhage | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Injection site nodule | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Injection site pain | 2/6 (33.3%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Injection site pruritis | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Injection site reaction | 1/6 (16.7%) | 1/5 (20%) | 5/14 (35.7%) | 4/6 (66.7%) | ||||
| Malaise | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Oedema | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Pain | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Pyrexia | 0/6 (0%) | 1/5 (20%) | 1/14 (7.1%) | 3/6 (50%) | ||||
| Hepatobiliary disorders | ||||||||
| Hyperbilirubinaemia | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Infections and infestations | ||||||||
| Hypogammaglobulinaemia | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Cellulitis | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Cystitis | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Lung Infection | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Sinusitis | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Upper respiratory tract infection | 1/6 (16.7%) | 0/5 (0%) | 3/14 (21.4%) | 2/6 (33.3%) | ||||
| Urinary tract infection | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Fall | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Procedural pain | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Blood alkaline phosphatase increased | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Cardiac murmur | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Hepatic enzyme increased | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Inspiratory capacity decreased | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Intraocular pressure test abnormal | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Neutrophil count decreased | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Platelet count decreased | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Spinal myelogram | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Weight decreased | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 2/6 (33.3%) | ||||
| Dehydration | 2/6 (33.3%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Hyperkalaemia | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Hyperuricaemia | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Hypokalaemia | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/6 (0%) | 1/5 (20%) | 1/14 (7.1%) | 3/6 (50%) | ||||
| Arthritis | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Back pain | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 3/6 (50%) | ||||
| Bone pain | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Gout | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Joint swelling | 1/6 (16.7%) | 0/5 (0%) | 0/14 (0%) | 0/6 (0%) | ||||
| Muscle spasms | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Musculoskeletal disorder | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Musculoskeletal pain | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Musculoskeletal stiffness | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Myalgia | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 2/6 (33.3%) | ||||
| Pain in extremity | 2/6 (33.3%) | 0/5 (0%) | 1/14 (7.1%) | 3/6 (50%) | ||||
| Nervous system disorders | ||||||||
| Brachial plexopathy | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Dizziness | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 2/6 (33.3%) | ||||
| Dysgeusia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Headache | 0/6 (0%) | 2/5 (40%) | 3/14 (21.4%) | 2/6 (33.3%) | ||||
| Hypoaesthesia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Memory impairment | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Neuralgia | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Neuropathy peripheral | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Paraesthesia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Peripheral sensory neuropathy | 1/6 (16.7%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Psychiatric disorders | ||||||||
| Confusional state | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Insomnia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Renal and urinary disorders | ||||||||
| Dysuria | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Haematuria | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Pollakiuria | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 2/6 (33.3%) | ||||
| Dyspnoea | 0/6 (0%) | 0/5 (0%) | 3/14 (21.4%) | 1/6 (16.7%) | ||||
| Epistaxis | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 0/6 (0%) | ||||
| Hypoxia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Productive cough | 1/6 (16.7%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Upper-airway cough syndrome | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 0/6 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Night sweats | 0/6 (0%) | 0/5 (0%) | 2/14 (14.3%) | 2/6 (33.3%) | ||||
| Pain of skin | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Rash | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Rash maculo-papular | 0/6 (0%) | 0/5 (0%) | 1/14 (7.1%) | 1/6 (16.7%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 0/6 (0%) | 1/5 (20%) | 0/14 (0%) | 0/6 (0%) | ||||
| Haematoma | 1/6 (16.7%) | 0/5 (0%) | 2/14 (14.3%) | 1/6 (16.7%) | ||||
| Hot flush | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
| Hypotension | 0/6 (0%) | 0/5 (0%) | 0/14 (0%) | 1/6 (16.7%) | ||||
Limitations/Caveats
Early termination leading to small numbers of subjects analyzed.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Idera staff in collaboration with the Investigator will be responsible for writing presentations and manuscripts for publication. Investigators will not be allowed to publish or present the data from this study without prior agreement with Idera.
Results Point of Contact
| Name/Title | Idera Medical Monitor |
|---|---|
| Organization | Idera Pharmaceuticals |
| Phone | 617-679-5500 |
| clinicaltrials@iderapharma.com |
Responsible Party:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02092909
Other Study ID Numbers:
- 8400-401
First Posted:
Mar 20, 2014
Last Update Posted:
Sep 10, 2019
Last Verified:
Aug 1, 2019