Trial Outcomes & Findings for Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers (NCT NCT01585428)
NCT ID: NCT01585428
Last Updated: 2018-03-07
Results Overview
Patients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
4 months after cell infusion
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
Cervical
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
11
|
|
Overall Study
COMPLETED
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cervical
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Overall Study
Death during treatment
|
1
|
0
|
Baseline Characteristics
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers
Baseline characteristics by cohort
| Measure |
Cervical
n=18 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
n=11 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
Total
n=29 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
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 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
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 months after cell infusionPatients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Outcome measures
| Measure |
Cervical
n=18 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
n=11 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Number of Participants With an Objective Clinical Response
Partial Response
|
3 Participants
|
2 Participants
|
|
Number of Participants With an Objective Clinical Response
Complete Response
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Objective Clinical Response
Progressive Disease
|
12 Participants
|
8 Participants
|
|
Number of Participants With an Objective Clinical Response
Stable Disease
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 51 months and 18 daysHere is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). 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. A non-serious adverse event is any untoward medical occurrence.
Outcome measures
| Measure |
Cervical
n=18 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
n=11 Participants
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Number of Patients With Serious and Non-serious Adverse Events
|
18 Participants
|
11 Participants
|
Adverse Events
Cervical
Serious events: 4 serious events
Other events: 17 other events
Deaths: 1 deaths
NonCervical
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervical
n=18 participants at risk
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
n=11 participants at risk
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Platelets
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Creatinine
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Renal and urinary disorders
Renal failure
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Nervous system disorders
Confusion
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Renal and urinary disorders
Cystitis
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Febrile neutropenia
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
18.2%
2/11 • Number of events 2 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Renal and urinary disorders
Obstruction, GU::Ureter
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
Other adverse events
| Measure |
Cervical
n=18 participants at risk
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
NonCervical
n=11 participants at risk
Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.9%
16/18 • Number of events 16 • 51 months and 18 days
|
72.7%
8/11 • Number of events 8 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
55.6%
10/18 • Number of events 10 • 51 months and 18 days
|
72.7%
8/11 • Number of events 8 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
94.4%
17/18 • Number of events 18 • 51 months and 18 days
|
90.9%
10/11 • Number of events 10 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
94.4%
17/18 • Number of events 17 • 51 months and 18 days
|
100.0%
11/11 • Number of events 11 • 51 months and 18 days
|
|
Blood and lymphatic system disorders
Platelets
|
94.4%
17/18 • Number of events 17 • 51 months and 18 days
|
100.0%
11/11 • Number of events 11 • 51 months and 18 days
|
|
Cardiac disorders
Hypotension
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
27.3%
3/11 • Number of events 3 • 51 months and 18 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
27.8%
5/18 • Number of events 5 • 51 months and 18 days
|
27.3%
3/11 • Number of events 3 • 51 months and 18 days
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Number of events 3 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Gastrointestinal disorders
Hemorrhage, GI:: Lower GI NOS
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
6/18 • Number of events 6 • 51 months and 18 days
|
27.3%
3/11 • Number of events 3 • 51 months and 18 days
|
|
Infections and infestations
Infection
|
33.3%
6/18 • Number of events 6 • 51 months and 18 days
|
54.5%
6/11 • Number of events 6 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Creatinine
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
27.3%
3/11 • Number of events 3 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Nervous system disorders
Confusion
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
18.2%
2/11 • Number of events 2 • 51 months and 18 days
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
18.2%
2/11 • Number of events 2 • 51 months and 18 days
|
|
Nervous system disorders
Syncope (fainting)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
General disorders
Pain::Abdomen NOS
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
38.9%
7/18 • Number of events 7 • 51 months and 18 days
|
45.5%
5/11 • Number of events 5 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
38.9%
7/18 • Number of events 7 • 51 months and 18 days
|
18.2%
2/11 • Number of events 2 • 51 months and 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Oliguria)
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
General disorders
Rigors/chills
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Nervous system disorders
Mental status
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Reproductive system and breast disorders
Hemorrhage, GU::Vagina
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
11.1%
2/18 • Number of events 2 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Renal and urinary disorders
Obstruction, GU::Ureter
|
5.6%
1/18 • Number of events 1 • 51 months and 18 days
|
0.00%
0/11 • 51 months and 18 days
|
|
Nervous system disorders
Pain::Head/Headache
|
0.00%
0/18 • 51 months and 18 days
|
9.1%
1/11 • Number of events 1 • 51 months and 18 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place