Trial Outcomes & Findings for Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of 12/01/2009) (NCT NCT00562640)
NCT ID: NCT00562640
Last Updated: 2023-09-15
Results Overview
Participant toxicity will be evaluated by using NCI CTCAE v3.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of 12/01/2009)
Baseline characteristics by cohort
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=39 Participants
|
52 years
n=41 Participants
|
63.5 years
n=35 Participants
|
63 years
n=31 Participants
|
61 years
n=146 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 2 yearsParticipant toxicity will be evaluated by using NCI CTCAE v3.0
Outcome measures
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Number of Participants Assessed for Safety and Tolerability as Assessed by NCI CTCAE v3.0
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Total Number of Dose Limiting Toxicities/DLT's
|
0 Dose Limiting Toxicities/DLTs
|
0 Dose Limiting Toxicities/DLTs
|
0 Dose Limiting Toxicities/DLTs
|
0 Dose Limiting Toxicities/DLTs
|
PRIMARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Mean Overall Survival
|
11.7 months
Interval 1.5 to 21.9
|
5.7 months
Interval 1.0 to 12.0
|
22.5 months
Interval 1.0 to 32.0
|
21.4 months
Interval 20.0 to 22.8
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 Participants
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Best Response
Progressive Disease
|
3 participants
|
3 participants
|
3 participants
|
2 participants
|
|
Best Response
Stable Disease
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Best Response
Not Evaluable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
WT1 Specific T Cells 5 x 10^6/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
WT1 Specific T Cells 2 x 10^7/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
WT1 Specific T Cells 5 x 10^7/m2
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
WT1 Specific T Cells 1 x 10^8/m2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
General disorders
Death not assoc with CTCAE term - Death NOS
|
100.0%
3/3 • 3 years
|
100.0%
3/3 • 3 years
|
100.0%
4/4 • 3 years
|
100.0%
2/2 • 3 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Small bowel obstruction - NOS
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Pneumonia(lung)
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
Other adverse events
| Measure |
WT1 Specific T Cells 5 x 10^6/m2
n=3 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 2 x 10^7/m2
n=3 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 5 x 10^7/m2
n=4 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
WT1 Specific T Cells 1 x 10^8/m2
n=2 participants at risk
This is a phase I dose escalating trial designed to identify tolerable, clinically active doses of Wilms' tumor gene (WT1) peptide sensitized T cells when administered alone or with nonmyelosuppressive chemotherapy in patients with recurrent or persistent, evaluable WT1+ ovarian, primary peritoneal, or fallopian tube carcinomas.
|
|---|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 3 years
|
100.0%
3/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/4 • 3 years
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
75.0%
3/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Reproductive system and breast disorders
Pain - Pelvis
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
25.0%
1/4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
75.0%
3/4 • 3 years
|
0.00%
0/2 • 3 years
|
Additional Information
Dr. Roisin O'Cearbhaill, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place