Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL
Study Details
Study Description
Brief Summary
This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DI-Leu16-IL2 1.0 mg/m^2 Participants will receive DI-Leu16-IL2 1.0 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects. |
Drug: DI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
|
Experimental: DI-Leu16-IL2 2.0 mg/m^2 Participants will receive DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects. |
Drug: DI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria [First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months)]
BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1)Disappearance of all detectable clinical and radiological evidence of disease; 2)lymph nodes (LN) regressed to normal size; 3)other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4)clear bone marrow(BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 centimeters (cm) in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.
- Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study [Baseline, end of study (EOS) (up to approximately 32 months)]
Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101.
- Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study [Baseline, EOS (up to approximately 32 months)]
Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm
Secondary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [First dose of study drug up to EOS (up to 20 months)]
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality [First dose of study drug up to EOS (up to 20 months)]
TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant hematology and serum chemistry abnormalities were identified at the Investigator's discretion.
- Number of Participants With a Clinically Significant Abnormal Physical Exam [First dose of study drug up to EOS (up to 20 months)]
Clinically significant abnormal physical exams included extremities, head, ears, eyes, nose, throat, abdomen, respiratory system, lymphatic system, and integumentary system. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant abnormal physical exams were identified at the Investigator's discretion.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants currently entered on Alopexx Oncology Study AO-101
-
Participants who received 6 cycles of DI-Leu16-IL2 on Study AO-101.
-
Documented clinical benefit following 6th cycle of DI-Leu16-IL2
-
Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
-
Participants must have received prior Rituximab-containing therapy.
-
Participants in this extension study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months.
-
Provide written informed consent prior to any study procedures.
Exclusion Criteria:
-
Pregnant or lactating female
-
An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
-
Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcAb) or hepatitis B surface antigen (HbsAg). Participants who are sero-positive only, that is, surface antibody positive [HbsAb], are permitted.
-
Other significant active infection
-
Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
-
Uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury [mmHg]) or hypotension (systolic ≤ 90 mmHg)
-
History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | City of Hope | Duarte | California | United States | 91010 |
2 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
3 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Alopexx Oncology, LLC
Investigators
- Study Director: Daniel Vlock, MD, Alopexx Oncology, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- King DM, Albertini MR, Schalch H, Hank JA, Gan J, Surfus J, Mahvi D, Schiller JH, Warner T, Kim K, Eickhoff J, Kendra K, Reisfeld R, Gillies SD, Sondel P. Phase I clinical trial of the immunocytokine EMD 273063 in melanoma patients. J Clin Oncol. 2004 Nov 15;22(22):4463-73. Epub 2004 Oct 13.
- Ko YJ, Bubley GJ, Weber R, Redfern C, Gold DP, Finke L, Kovar A, Dahl T, Gillies SD. Safety, pharmacokinetics, and biological pharmacodynamics of the immunocytokine EMD 273066 (huKS-IL2): results of a phase I trial in patients with prostate cancer. J Immunother. 2004 May-Jun;27(3):232-9.
- Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, Levy R. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994 Oct 15;84(8):2457-66.
- AO-101-EXT
Study Results
Participant Flow
Recruitment Details | Participants who, in the opinion of the Investigator, exhibited a beneficial effect without a dose-limiting toxicity (DLT) in the dose-escalation Study AO-101 (NCT01874288) (Main Study) were allowed to continue treatment with DI-Leu16-IL2 in this open-label extension study. |
---|---|
Pre-assignment Detail |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Period Title: Overall Study | ||
STARTED | 3 | 2 |
Received at Least 1 Dose of Study Drug | 3 | 2 |
COMPLETED | 0 | 1 |
NOT COMPLETED | 3 | 1 |
Baseline Characteristics
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 | Total |
---|---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Total of all reporting groups |
Overall Participants | 3 | 2 | 5 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
2
66.7%
|
0
0%
|
2
40%
|
>=65 years |
1
33.3%
|
2
100%
|
3
60%
|
Sex: Female, Male (Count of Participants) | |||
Female |
1
33.3%
|
2
100%
|
3
60%
|
Male |
2
66.7%
|
0
0%
|
2
40%
|
Outcome Measures
Title | Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria |
---|---|
Description | BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1)Disappearance of all detectable clinical and radiological evidence of disease; 2)lymph nodes (LN) regressed to normal size; 3)other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4)clear bone marrow(BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 centimeters (cm) in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion. |
Time Frame | First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 3 | 2 |
CR |
0
0%
|
1
50%
|
CRu |
0
0%
|
0
0%
|
PR |
0
0%
|
0
0%
|
SD |
1
33.3%
|
0
0%
|
PD |
1
33.3%
|
1
50%
|
Title | Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study |
---|---|
Description | Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. |
Time Frame | Baseline, end of study (EOS) (up to approximately 32 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 2 | 0 |
Mean (Standard Deviation) [percent change] |
-22.86066
(9.805965)
|
Title | Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study |
---|---|
Description | Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm |
Time Frame | Baseline, EOS (up to approximately 32 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 2 | 0 |
Mean (Standard Deviation) [percent change] |
-11.638
(1.5001)
|
Title | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
---|---|
Description | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
Time Frame | First dose of study drug up to EOS (up to 20 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 3 | 2 |
Any TEAEs |
3
100%
|
1
50%
|
SAEs |
2
66.7%
|
0
0%
|
Title | Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality |
---|---|
Description | TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant hematology and serum chemistry abnormalities were identified at the Investigator's discretion. |
Time Frame | First dose of study drug up to EOS (up to 20 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 3 | 2 |
Count of Participants [Participants] |
3
100%
|
0
0%
|
Title | Number of Participants With a Clinically Significant Abnormal Physical Exam |
---|---|
Description | Clinically significant abnormal physical exams included extremities, head, ears, eyes, nose, throat, abdomen, respiratory system, lymphatic system, and integumentary system. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant abnormal physical exams were identified at the Investigator's discretion. |
Time Frame | First dose of study drug up to EOS (up to 20 months) |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all enrolled participants who received at least 1 dose of study drug. |
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 |
---|---|---|
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
Measure Participants | 3 | 2 |
Count of Participants [Participants] |
3
100%
|
1
50%
|
Adverse Events
Time Frame | First dose of study drug up to EOS (up to 20 months) | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety population included all enrolled participants who received at least 1 dose of study drug. | |||
Arm/Group Title | DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 | ||
Arm/Group Description | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | ||
All Cause Mortality |
||||
DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/2 (0%) | ||
Serious Adverse Events |
||||
DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/3 (66.7%) | 0/2 (0%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/3 (33.3%) | 0/2 (0%) | ||
Gastrointestinal disorders | ||||
Melena | 1/3 (33.3%) | 0/2 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
DI-Leu16-IL2 1.0 mg/m^2 | DI-Leu16-IL2 2.0 mg/m^2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/3 (100%) | 1/2 (50%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/3 (33.3%) | 0/2 (0%) | ||
Eosinophilia | 1/3 (33.3%) | 0/2 (0%) | ||
Cardiac disorders | ||||
Tachycardia | 1/3 (33.3%) | 0/2 (0%) | ||
Ear and labyrinth disorders | ||||
Cerumen impaction | 0/3 (0%) | 1/2 (50%) | ||
Hypoacusis | 0/3 (0%) | 1/2 (50%) | ||
Eye disorders | ||||
Diplopia | 1/3 (33.3%) | 0/2 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal pain | 1/3 (33.3%) | 0/2 (0%) | ||
Dry mouth | 1/3 (33.3%) | 1/2 (50%) | ||
Diarrhoea | 1/3 (33.3%) | 0/2 (0%) | ||
Oral pain | 1/3 (33.3%) | 0/2 (0%) | ||
Toothache | 1/3 (33.3%) | 0/2 (0%) | ||
General disorders | ||||
Chills | 1/3 (33.3%) | 0/2 (0%) | ||
Fatigue | 1/3 (33.3%) | 0/2 (0%) | ||
Injection site erythema | 1/3 (33.3%) | 1/2 (50%) | ||
Injection site induration | 1/3 (33.3%) | 1/2 (50%) | ||
Injection site oedema | 1/3 (33.3%) | 0/2 (0%) | ||
Injection site pain | 1/3 (33.3%) | 0/2 (0%) | ||
Oedema peripheral | 1/3 (33.3%) | 0/2 (0%) | ||
Injection site pruritus | 1/3 (33.3%) | 1/2 (50%) | ||
Injection site swelling | 1/3 (33.3%) | 1/2 (50%) | ||
Pain | 1/3 (33.3%) | 0/2 (0%) | ||
Oedema | 1/3 (33.3%) | 0/2 (0%) | ||
Injection site inflammation | 0/3 (0%) | 1/2 (50%) | ||
Injection site mass | 0/3 (0%) | 1/2 (50%) | ||
Immune system disorders | ||||
Hypogammaglobulinaemia | 0/3 (0%) | 1/2 (50%) | ||
Infections and infestations | ||||
Cellulitis | 1/3 (33.3%) | 0/2 (0%) | ||
Rhinitis | 1/3 (33.3%) | 0/2 (0%) | ||
Upper respiratory tract infection | 1/3 (33.3%) | 1/2 (50%) | ||
Otitis media acute | 0/3 (0%) | 1/2 (50%) | ||
Sinusitis | 0/3 (0%) | 1/2 (50%) | ||
Injury, poisoning and procedural complications | ||||
Fall | 2/3 (66.7%) | 0/2 (0%) | ||
Ligament injury | 1/3 (33.3%) | 0/2 (0%) | ||
Investigations | ||||
Blood creatinine increased | 1/3 (33.3%) | 0/2 (0%) | ||
Blood glucose increased | 1/3 (33.3%) | 0/2 (0%) | ||
Blood potassium increased | 1/3 (33.3%) | 0/2 (0%) | ||
Blood urea increased | 1/3 (33.3%) | 0/2 (0%) | ||
Hematocrit decreased | 1/3 (33.3%) | 0/2 (0%) | ||
Protein total increased | 1/3 (33.3%) | 0/2 (0%) | ||
Weight decreased | 1/3 (33.3%) | 0/2 (0%) | ||
Metabolism and nutrition disorders | ||||
Hyperglycaemia | 1/3 (33.3%) | 0/2 (0%) | ||
Hyperkalaemia | 1/3 (33.3%) | 0/2 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Bone pain | 1/3 (33.3%) | 0/2 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Acoustic neuroma | 0/3 (0%) | 1/2 (50%) | ||
Nervous system disorders | ||||
Memory impairment | 1/3 (33.3%) | 0/2 (0%) | ||
Neurotoxicity | 1/3 (33.3%) | 0/2 (0%) | ||
Nystagmus | 1/3 (33.3%) | 0/2 (0%) | ||
Dizziness | 1/3 (33.3%) | 0/2 (0%) | ||
Headache | 0/3 (0%) | 1/2 (50%) | ||
Hypoaesthesia | 0/3 (0%) | 1/2 (50%) | ||
Psychiatric disorders | ||||
Anxiety | 1/3 (33.3%) | 0/2 (0%) | ||
Insomnia | 1/3 (33.3%) | 1/2 (50%) | ||
Renal and urinary disorders | ||||
Chromaturia | 1/3 (33.3%) | 0/2 (0%) | ||
Urine odour abnormal | 1/3 (33.3%) | 0/2 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Dry throat | 1/3 (33.3%) | 0/2 (0%) | ||
Dyspnoea | 1/3 (33.3%) | 0/2 (0%) | ||
Cough | 1/3 (33.3%) | 0/2 (0%) | ||
Nasal Congestion | 1/3 (33.3%) | 0/2 (0%) | ||
Upper respiratory tract congestion | 1/3 (33.3%) | 0/2 (0%) | ||
Rhinorrhoea | 0/3 (0%) | 1/2 (50%) | ||
Sinus congestion | 0/3 (0%) | 1/2 (50%) | ||
Skin and subcutaneous tissue disorders | ||||
Skin hyperpigmentation | 1/3 (33.3%) | 0/2 (0%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 1/3 (33.3%) | 0/2 (0%) | ||
Hypotension | 1/3 (33.3%) | 1/2 (50%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Alopexx Oncology, LLC |
Phone | |
daniel.vlock@alopexx.com |
- AO-101-EXT