Trial Outcomes & Findings for Imaging Study for FdCyd and THU Cancer Treatment (NCT NCT01479348)
NCT ID: NCT01479348
Last Updated: 2020-06-02
Results Overview
\[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. 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. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Within 5 days after interventions
Results posted on
2020-06-02
Participant Flow
No participants were enrolled in the 2/Oral Tetrahydrouridine (THU) Group.
Participant milestones
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of THU = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
2/Oral Tetrahydrouridine (THU)
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of THU = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Study for FdCyd and THU Cancer Treatment
Baseline characteristics by cohort
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 Participants
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
55.46 years
STANDARD_DEVIATION 15.19 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
|
Baseline Tumor Types
Head & Neck Carcinoma
|
2 Participants
n=93 Participants
|
|
Baseline Tumor Types
Non-Small Cell Lung Carcinoma
|
2 Participants
n=93 Participants
|
|
Baseline Tumor Types
Hepatocellular Carcinoma
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Within 5 days after interventions\[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. 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. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event.
Outcome measures
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 Participants
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 1 Adverse Events
|
0 adverse events
|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 2, Grade 2 Hypoalbuminemia
|
1 adverse events
|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 2, Grade 3 Anemia
|
1 adverse events
|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 3 Adverse Events
|
0 adverse events
|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 4 Adverse Events
|
0 adverse events
|
|
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Day 5 Adverse Events
|
0 adverse events
|
PRIMARY outcome
Timeframe: 1 yearRadiation dosimetry was determined based on the first patients. This involved making region of interest measurements on the scan for each major organ and measuring the uptake. Using standard dosimetry software this is converted into mSv/MBq, a standard measure of dosimetry. The software is known as Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA) and is commonly used to generate this kind of data.
Outcome measures
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 Participants
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Skin
|
8.65 mSv/MBq
Standard Deviation 1.19
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Spleen
|
1.69 mSv/MBq
Standard Deviation 5.55
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Uterus
|
1.63 mSv/MBq
Standard Deviation 4.99
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Adrenals
|
1.83 mSv/MBq
Standard Deviation 9.3
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Brain
|
8.17 mSv/MBq
Standard Deviation 2.04
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Breasts
|
1.03 mSv/MBq
Standard Deviation 1.01
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Gallbladder wall
|
4.05 mSv/MBq
Standard Deviation 7.55
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Lower large intestine wall
|
2.52 mSv/MBq
Standard Deviation 7.82
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Small intestine
|
2.13 mSv/MBq
Standard Deviation 4.57
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Stomach wall
|
1.90 mSv/MBq
Standard Deviation 3.27
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Upper large intestine wall
|
2.04 mSv/MBq
Standard Deviation 6.43
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Heart wall
|
1.10 mSv/MBq
Standard Deviation 1.82
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Kidneys
|
5.26 mSv/MBq
Standard Deviation 2.23
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Liver
|
6.02 mSv/MBq
Standard Deviation 2.74
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Lungs
|
1.82 mSv/MBq
Standard Deviation 7.10
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Muscle
|
1.16 mSv/MBq
Standard Deviation 1.35
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Ovaries
|
1.57 mSv/MBq
Standard Deviation 2.22
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Pancreas
|
1.63 mSv/MBq
Standard Deviation 4.27
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Red marrow
|
1.14 mSv/MBq
Standard Deviation 2.19
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Osteogenic cells
|
1.71 mSv/MBq
Standard Deviation 6.41
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Testes
|
1.03 mSv/MBq
Standard Deviation 2.38
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Thymus
|
1.12 mSv/MBq
Standard Deviation 3.01
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Thyroid
|
8.23 mSv/MBq
Standard Deviation 4.39
|
|
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Urinary bladder wall
|
7.96 mSv/MBq
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: 9 minutes, 32 minutes, 56 minutes and 2 hours after injectionPopulation: One participant contributed to data in each row.
Participants were scanned by positron emission tomography (PET) and lesions were measured at 4 time points after injection.
Outcome measures
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 Participants
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 1 L. Parotid adenosquam. cell ca at 9 min
|
1.4 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 1 L. Parotid adenosquam. cell ca at 32 min
|
1.5 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 1 L. Parotid adenosquam. cell ca at 56 min
|
1.5 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 1 L. Parotid adenosquam. cell ca at 2 hrs
|
1.6 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 2 R. Parapharyngeal Spindle Cell Ca at 9 min
|
1.9 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 2 R. Parapharyngeal Spindle Cell Ca at 32 min
|
1.7 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 2 R. Parapharyngeal Spindle Cell Ca at 56 min
|
1.7 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 2 R. Parapharyngeal Spindle Cell Ca at 2 hrs
|
1.6 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 3 Non-small Cell Lung Ca at 9 min
|
1.4 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 3 Non-small Cell Lung Ca at 32 min
|
1.4 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 3 Non-small Cell Lung Ca at 56 min
|
1.5 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 3 Non-small Cell Lung Ca at 2 hrs
|
1.7 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 4 Non-small Cell Lung Ca at 9 min
|
2.4 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 4 Non-small Cell Lung Ca at 32 min
|
2.1 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 4 Non-small Cell Lung Ca at 56 min
|
1.6 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 4 Non-small Cell Lung Ca at 2 hrs
|
2.0 TBR ratio
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 5 Hepatocellular Ca at 9 min
|
NA TBR ratio
Activity within the tumor was not clearly discernable from remainder of liver parenchyma, thus TBRs are not included for Pt. 5 because of concern about reporting misleading values in setting of high background/surrounding liver uptake.
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 5 Hepatocellular Ca at 32 min
|
NA TBR ratio
Activity within the tumor was not clearly discernable from remainder of liver parenchyma, thus TBRs are not included for Pt. 5 because of concern about reporting misleading values in setting of high background/surrounding liver uptake.
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 5 Hepatocellular Ca at 56 min
|
NA TBR ratio
Activity within the tumor was not clearly discernable from remainder of liver parenchyma, thus TBRs are not included for Pt. 5 because of concern about reporting misleading values in setting of high background/surrounding liver uptake.
|
|
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Pt 5 Hepatocellular Ca at 2 hrs
|
NA TBR ratio
Activity within the tumor was not clearly discernable from remainder of liver parenchyma, thus TBRs are not included for Pt. 5 because of concern about reporting misleading values in setting of high background/surrounding liver uptake.
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 20 months and 12 days.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for 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 |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 Participants
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
2 Participants
|
Adverse Events
1/Intravenous (IV) Tetrahydrouridine (THU)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 participants at risk
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
General disorders
Death NOS
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 20 months and 12 days.
|
Other adverse events
| Measure |
1/Intravenous (IV) Tetrahydrouridine (THU)
n=5 participants at risk
\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 20 months and 12 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 20 months and 12 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place