Trial Outcomes & Findings for Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) (NCT NCT03410030)
NCT ID: NCT03410030
Last Updated: 2026-07-23
Results Overview
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the total dose received of ascorbic acid (g/m\^2) by participants was measured.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
From enrollment through end of treatment, up to 40 weeks
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
Ascorbic Acid 25 g/m^2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.50 g/m^2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 56.25 g/m^2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 75 g/m^2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials Ascorbic Acid: combination therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
7
|
0
|
|
Overall Study
COMPLETED
|
6
|
4
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
Baseline characteristics by cohort
| Measure |
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.50 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 56.25 g/m^2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
67.3 years
n=9 Participants
|
59.9 years
n=27 Participants
|
63.9 years
n=267 Participants
|
63.9 years
n=265 Participants
|
|
Sex: Female, Male
Gender · Female
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
|
Sex: Female, Male
Gender · Male
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · White
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
|
ECOG Score
ECOG Score 0
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
|
Primary Site of Tumor
Tail of Pancreas
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
ECOG Score
ECOG Score 1
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Baseline CA 19-9
Normal
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Baseline CA 19-9
Elevated
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
|
Primary Site of Tumor
Body of Pancreas
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Primary Site of Tumor
Head of Pancreas
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Primary Site of Tumor
Neck of Pancreas
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Tumor Resection
No Resection
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
|
Tumor Resection
Whipple Procedure
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Body Surface Area
|
1.8 (m^2)
STANDARD_DEVIATION 0.3 • n=9 Participants
|
1.9 (m^2)
STANDARD_DEVIATION 0.2 • n=27 Participants
|
1.9 (m^2)
STANDARD_DEVIATION 0.2 • n=267 Participants
|
1.9 (m^2)
STANDARD_DEVIATION 0.2 • n=265 Participants
|
|
Time Since Diagnosis
|
0.4 years
STANDARD_DEVIATION 0.9 • n=9 Participants
|
0.2 years
STANDARD_DEVIATION 0.2 • n=27 Participants
|
0.1 years
STANDARD_DEVIATION 0.1 • n=267 Participants
|
0.2 years
STANDARD_DEVIATION 0.5 • n=265 Participants
|
|
Neutrophil to Lymphocyte Ratio (NLR)
|
3.8 calculated ratio
STANDARD_DEVIATION 0.7 • n=9 Participants
|
6.4 calculated ratio
STANDARD_DEVIATION 3.9 • n=27 Participants
|
5.0 calculated ratio
STANDARD_DEVIATION 1.3 • n=267 Participants
|
4.9 calculated ratio
STANDARD_DEVIATION 2.2 • n=265 Participants
|
|
Neutrophil to Lymphocyte Ratio (NLR)
Low (≤ 5)
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
|
Neutrophil to Lymphocyte Ratio (NLR)
High (> 5)
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Albumin g/dL
|
3.3 g/dL
STANDARD_DEVIATION 0.3 • n=9 Participants
|
3.1 g/dL
STANDARD_DEVIATION 0.3 • n=27 Participants
|
3.6 g/dL
STANDARD_DEVIATION 0.5 • n=267 Participants
|
3.4 g/dL
STANDARD_DEVIATION 0.4 • n=265 Participants
|
|
Sites of Metastatic Disease
Liver, Ascites
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Sites of Metastatic Disease
Lung
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Sites of Metastatic Disease
Lymph Node
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Sites of Metastatic Disease
Liver & Lung
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Sites of Metastatic Disease
Liver & Lymph Nodes
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Sites of Metastatic Disease
Other
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
History of Prior Treatment
No Prior Treatment
|
5 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
|
History of Prior Treatment
Adjuvant & Neoadjuvant
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: From enrollment through end of treatment, up to 40 weeksTo determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the total dose received of ascorbic acid (g/m\^2) by participants was measured.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)]
|
589.1 Dose (g/m^2)
Standard Deviation 135.7
|
235.3 Dose (g/m^2)
Standard Deviation 66.3
|
410.4 Dose (g/m^2)
Standard Deviation 62.0
|
PRIMARY outcome
Timeframe: From enrollment through end of treatment, up to 40 weeksTo determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in days is reported.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)]
|
149.0 Days
Standard Deviation 54.2
|
235.5 Days
Standard Deviation 51.9
|
165.9 Days
Standard Deviation 51.4
|
PRIMARY outcome
Timeframe: From enrollment through end of treatment, up to 40 weeksTo determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in weeks is reported.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)]
|
21.3 Weeks
Standard Deviation 7.7
|
33.6 Weeks
Standard Deviation 7.4
|
23.7 Weeks
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: 18 weeksPreliminary efficacy as measured by disease control rate (DCR), defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) at 18 weeks according to RECIST v1.1. CR = disappearance of all target lesions; PR = at least 30% decrease in sum of the longest diameters for target lesions, SD = insufficient change to qualify for PR or progressive disease \[defined as at least 20% increase in sum of the longest diameters for target lesions\].
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Disease Control Rate (CR+PR+SD at 18 Weeks)
|
57.1 Percentage of participants
Interval 9.9 to 81.6
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
PRIMARY outcome
Timeframe: From enrollment through end of treatment, up to 36 weeksBest overall response according to RECIST v1.1. Complete response (CR) = disappearance of all target lesions; Partial response (PD) = at least 30% decrease in sum of the longest diameters for target lesions; Stable disease (SD) = insufficient change to qualify for PR or PD; Progressive disease (PD) = at least 20% increase in sum of the longest diameters for target lesions.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Best Overall Response
Progressive Disease (PD)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Partial Response (PR)
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Best Overall Response
Stable Disease (SD)
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From enrollment through 30 days after the end of treatment, up to 40 weeksPopulation: Mean Number of Grade 3/4 Adverse Events by Treatment
Incidence of adverse events reported according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=17 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Incidence of Toxicities
25 g/m2
|
—
|
4.0 count of adverse event term
Standard Deviation 3.4
|
—
|
|
Incidence of Toxicities
37.5 g/m2
|
—
|
3.0 count of adverse event term
Standard Deviation 1.4
|
—
|
|
Incidence of Toxicities
56.25 g/m2
|
—
|
3.1 count of adverse event term
Standard Deviation 2.3
|
—
|
SECONDARY outcome
Timeframe: From enrollment through study completion, up to 40 weeksPopulation: n=14 participants had elevated tumor markers at baseline (n=5 in Ascorbic Acid 25g/m\^2 arm, n=3 in Ascorbic Acid 37.5 Gm\^2 arm, and n=6 in Ascorbic Acid 56.25 G/m\^2 arm). n=3 participants were excluded from this analysis because they did not have elevated tumor markers at baseline.
The percentage of patients who had elevated levels of tumor marker CA 19-9 (or CA-125/CEA if not expressors of CA 19-9) and had their levels normalize. Elevated levels were defined as any value \>35 U/mL for CA 19-9, \>35 U/mL for CA-125, and \>3 ng/mL for CEA. Normalization was defined as any patient who had elevated tumor marker values at baseline and decreased to CA 19-9 value of 0.0-35 U/mL, CA-125 value of 0.0-35 U/mL, or CEA value of 0.0-3 ng/mL during treatment.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=5 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=3 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Normalization of Tumor Markers by AA Treatment Group
CA-125 Normalized
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Normalization of Tumor Markers by AA Treatment Group
CA 19-9 Normalized
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Normalization of Tumor Markers by AA Treatment Group
CEA Normalized
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 12 weeks from last study treatment, assessed up to 3 yearsTelephone follow-up conducted every 12 weeks from the last dose of treatment to determine survival status.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Overall Survival
|
15.9 months
Interval 2.4 to
The upper bound of the confidence interval cannot be estimated due to an insufficient number of participants with events.
|
14.2 months
Interval 5.0 to
The upper bound of the confidence interval cannot be estimated due to an insufficient number of participants with events.
|
7.7 months
Interval 2.5 to
The upper bound of the confidence interval cannot be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Approximately 12 weeks from last study treatment, assessed up to 3 yearsTelephone follow-up conducted every 12 weeks from the last dose of treatment to determine status of disease progression.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Progression-free Survival
|
5.7 months
Interval 1.5 to 10.1
|
8.9 months
Interval 3.6 to
The upper bound of the confidence interval cannot be estimated due to an insufficient number of participants with events.
|
6.4 months
Interval 2.1 to
The upper bound of the confidence interval cannot be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From Cycle 1 to end of treatment, up to 40 weeksChanges in patient's self-reported quality of life as determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks patients to rank the severity of symptoms using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 18 questions to produce an MDASI-GI score on a 0-10 scale. MDASI-GI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Quality of Life: MD Anderson's Symptom Inventory-GI (MDASI-GI)
Start of Cycle 1
|
1.9 MDASI-GI Score
Standard Deviation 2.0 • Interval 0.6 to 2.1
|
1.8 MDASI-GI Score
Standard Deviation 1.5 • Interval 0.8 to 2.5
|
3.7 MDASI-GI Score
Standard Deviation 2.8 • Interval 1.6 to 6.9
|
|
Quality of Life: MD Anderson's Symptom Inventory-GI (MDASI-GI)
End of Treatment (EOT)
|
1.5 MDASI-GI Score
Standard Deviation 2.0
|
0.8 MDASI-GI Score
Standard Deviation 0.4
|
1.4 MDASI-GI Score
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: From start of Cycle 1 to end of treatment, up to 40 weeksChanges in patient's self-reported pain levels determined by administering the Brief Pain Inventory (BPI) - Pain Intensity (PI) assessment. This questionnaire asks about pain intensity using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 4 questions to output a BPI-PI score on a 0-10 scale. BPI-PI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
Outcome measures
| Measure |
Ascorbic Acid 56.25 gm/m2
n=7 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
|
Ascorbic Acid 25 g/m^2
n=6 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 Participants
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Quality of Life: Brief Pain Inventory (BPI) - Pain Intensity (PI)
Start of Cycle 1
|
2.4 BPI-PI Score
Standard Error 1.9
|
1.90 BPI-PI Score
Standard Error 1.8
|
3.5 BPI-PI Score
Standard Error 1.2
|
|
Quality of Life: Brief Pain Inventory (BPI) - Pain Intensity (PI)
End of Treatment (EOT)
|
0.9 BPI-PI Score
Standard Error 1.9
|
0.7 BPI-PI Score
Standard Error 0.9
|
3.0 BPI-PI Score
Standard Error 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 63 daysImaging completed to evaluate tumor texture on radiologic scans as a non-invasive imaging biomarker for response, biologic, pathologic and outcome measures.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 63 daysLab testing will be completed to evaluate the correlation between peak plasma concentration of ascorbic acid and response to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 63 daysTumor biopsy testing will be completed to evaluate potential biomarkers in the tumor including tumor immune cell infiltration, stromal activation, stem cell enumeration, metabolic profiles, whole exome and whole genome CN, ChIP-seq/ATAQ seq, IHC and PCR assays on immune cell populations, CAFs, stem cell content (CD133, Aldh) and Musashi
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 63 daysLab testing will be completed to evaluate potential biomarkers in the blood samples. Test may include CTCs/circCSC enumeration, Single CTC/circCSC transcription profiling, immune profiling \[CD4+CD8+ T cells, MDSC (IDO-1+HLR-DR-/lowCD33+CD11b+CD14+), Immunosuppressive plasmocytes (CD19+CD138+IgA+IL-10+PD-L1+), Th17 (CD3+gdTCR+IL-17A+), Treg (CD4+Foxp3+), Hypo-responsive NK cells (CD3-CD56+KIR-NKG2A-), cfDNA, GPC1+ exosomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 63 daysLab testing will be completed to evaluate changes in numbers of circulating tumor stem cells and macrophage lineage changes
Outcome measures
Outcome data not reported
Adverse Events
Ascorbic Acid 25 g/m^2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
Ascorbic Acid 37.5 g/m^2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Ascorbic Acid 56.25 g/m^2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Ascorbic Acid 25 g/m^2
n=6 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 56.25 g/m^2
n=7 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Hepatobiliary disorders
Colitis
|
0.00%
0/6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
Other adverse events
| Measure |
Ascorbic Acid 25 g/m^2
n=6 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 37.5 g/m^2
n=4 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
Ascorbic Acid 56.25 g/m^2
n=7 participants at risk
Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Ascorbic Acid: combination therapy
Paclitaxel protein-bound: combination therapy
Cisplatin: combination therapy
Gemcitabine: combination therapy
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
4/6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
100.0%
4/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
57.1%
4/7 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Vascular disorders
thrombocytopenia
|
83.3%
5/6 • Number of events 5 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
100.0%
4/4 • Number of events 4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
85.7%
6/7 • Number of events 6 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Immune system disorders
neutropenia
|
83.3%
5/6 • Number of events 5 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Blood and lymphatic system disorders
hypokalemia
|
66.7%
4/6 • Number of events 4 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.
Adverse events were collected according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place