Trial Outcomes & Findings for AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer (NCT NCT02298946)
NCT ID: NCT02298946
Last Updated: 2019-02-22
Results Overview
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Date treatment consent signed to date off study, approximately 24 months and 8 days
Results posted on
2019-02-22
Participant Flow
Participant milestones
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Overall Study
Did not receive treatment
|
2
|
0
|
|
Overall Study
Unevaluable
|
2
|
1
|
Baseline Characteristics
AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=8 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not meeting the definition for Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican,Puerto Rican,Cuban,Central or So. Amer/Oth
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Count of Participants with Pre-Treatment Biopsies
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 24 months and 8 daysPopulation: One patient (on dose level 1) after signing consent while waiting for radiation dosing, developed a spinal cord compression that needed emergent care at the local hospital. This patient was not treated. One patient (on dose level 1) after signing consent, developed a bowel obstruction prior to treatment.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Zero participants were analyzed because no participants experienced a CR or PR.
Duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and post infusion AMP-224 (e.g. 15 minutes after infusion ended)This outcome measure only represents the number of participants with metastatic colorectal cancer who had specimens collected for pre and post pharmacokinetic (PK) AMP-224 analyses.
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 Analyses
Post AMP-224
|
6 Participants
|
9 Participants
|
|
Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 Analyses
Pre AMP-224
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of study, which is date of death. Average time participants were followed was 10.6 months.Population: Patients were follow up post completion of the treatment medications for survival until date of their death. 2 patients were not evaluable since they did not receive treatment. 1 patient was lost to follow up after 3 cycles of treatment due to brain metastasis and treatment in another state.
Overall survival is defined as the time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Overall Survival in Patients With Colorectal Cancer Following Treatment With AMP-224 in Combination With SBRT
|
4.3 months
Interval 1.2 to 8.9
|
9.0 months
Interval 1.5 to 21.3
|
SECONDARY outcome
Timeframe: Post treatment, day 29 +/- 7 daysMandatory post treatment biopsies of the tumor were attempted on all patients.
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=8 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Count of Participants With Post-Treatment Biopsies
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression, an average of 2.6 months.Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Median Progression-free Survival in Patients With Colorectal Cancer
|
1.7 months
Interval 0.9 to 3.3
|
2.7 months
Interval 0.3 to 12.8
|
SECONDARY outcome
Timeframe: Restaging was done every 8 weeks for an average of 2.6 months.Population: All patients had restaging evaluations completed as per protocol. Response criteria in solid tumors(RECIST) were completed on every trial participate. No partial or complete responses were found in any patients.
Objective response will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as Complete Response + Partial Response. Briefly, complete response (CR) is defined as the disappearance of all target lesions, and Partial Response is defined as "at least" 30% decrease in the sum of the diameters of the target lesions from baseline measurement.
Outcome measures
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 Participants
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 Participants
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days
AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.
Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days
Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Objective Response Rate
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, D1, D29, and D57 (pre-infusion), D79, D85 and 90 days post last dose (D169)Population: Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.
Blood samples were collected to measure HAMA and HACA concentrations using the ELISA method in all patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 daysPopulation: Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre and post-infusion with all the AMP infusion and Day 1 at 8, 15, 29, 43, 57, and 71 hours.Population: Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. The lower limit of quantification (LLOQ) is the smallest concentration of the drug that can be reliably measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12.7 hours following intravenous (IV) infusion.Population: Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.
Time maximum drug absorption is reached in the blood following administration of AMP-224.
Outcome measures
Outcome data not reported
Adverse Events
DL1 - CTX, SBRTx1 Day, & AMP-224
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
DL2 - CTX, SBRTx3 Days, and AMP-224
Serious events: 2 serious events
Other events: 9 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 participants at risk
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 participants at risk
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
Other adverse events
| Measure |
DL1 - CTX, SBRTx1 Day, & AMP-224
n=6 participants at risk
Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
|
DL2 - CTX, SBRTx3 Days, and AMP-224
n=9 participants at risk
Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
|
|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
83.3%
5/6 • Number of events 14 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
88.9%
8/9 • Number of events 19 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
4/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
4/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
55.6%
5/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
5/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
88.9%
8/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
44.4%
4/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Blood bilirubin increased
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Endocrine disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Cholesterol high
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
55.6%
5/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
4/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
55.6%
5/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
44.4%
4/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
44.4%
4/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Infusion related reaction
|
50.0%
3/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
55.6%
5/9 • Number of events 12 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
3/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
88.9%
8/9 • Number of events 30 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Lymphocyte count increased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
44.4%
4/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
General disorders
Pain
|
66.7%
4/6 • Number of events 9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
55.6%
5/9 • Number of events 10 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Pancreatic enzymes decreased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 24 months and 8 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place