Trial Outcomes & Findings for Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine (NCT NCT03714555)
NCT ID: NCT03714555
Last Updated: 2023-10-18
Results Overview
Change in plasma CA19-9 level (at least 30%) from baseline
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results posted on
2023-10-18
Participant Flow
Participant milestones
| Measure |
Nab-Paclitaxel/Gemcitabine + DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
FOLFIRINOX +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
Single-Agent Gemcitabine +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
Baseline characteristics by cohort
| Measure |
Nab-Paclitaxel/Gemcitabine + DSF/Cu
n=1 Participants
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
FOLFIRINOX +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
Single-Agent Gemcitabine +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Alaska Native
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Pacific Rim
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
—
|
1 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Change in plasma CA19-9 level (at least 30%) from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Complete response rate as defined by CT scan using RECIST 1.1 criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Partial response as defined by CT scan using RECIST 1.1 criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Complete response as defined by CT scan using RECIST 1.1 criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Overall response rate as defined by CT scan using RECIST 1.1 criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until date of death assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
The length of time from the start of treatment that patients are still alive
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Change in serum albumin level as a result of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Change in body weight as a result of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment until the date of follow-up, 30 days after last treatmentPopulation: One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7Optional Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7
Outcome measures
Outcome data not reported
Adverse Events
Nab-Paclitaxel/Gemcitabine + DSF/Cu
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
FOLFIRINOX +DSF/Cu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-Agent Gemcitabine +DSF/Cu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nab-Paclitaxel/Gemcitabine + DSF/Cu
n=1 participants at risk
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
FOLFIRINOX +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
Single-Agent Gemcitabine +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
Other adverse events
| Measure |
Nab-Paclitaxel/Gemcitabine + DSF/Cu
n=1 participants at risk
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
FOLFIRINOX +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
Single-Agent Gemcitabine +DSF/Cu
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
|
|---|---|---|---|
|
Nervous system disorders
Transient Flushing/Sweats
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Nervous system disorders
Muscle Cramp/Burning
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Psychiatric disorders
Depression
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Cardiac disorders
Hypertension
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Nervous system disorders
Slurred Speach
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
—
0/0 • 6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place