Trial Outcomes & Findings for Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma (NCT NCT01470417)
NCT ID: NCT01470417
Last Updated: 2023-08-22
Results Overview
Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
4 - 8 weeks after neoadjuvant therapy
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Chemotherapy
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Chemotherapy
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Overall Study
Disease progression
|
0
|
2
|
Baseline Characteristics
Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=3 Participants
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
n=7 Participants
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
n=5 Participants
|
67.3 years
n=7 Participants
|
67.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 - 8 weeks after neoadjuvant therapyPopulation: The seven subjects included in this analysis had CA19-9 testing performed at baseline and again prior to surgery. Pre-operative CA19-9 testing was not performed for one subject so they were not included in this analysis nor were two subjects who were found to have progressive disease prior to completing neoadjuvant therapy.
Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.
Outcome measures
| Measure |
Chemotherapy
n=3 Participants
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
n=4 Participants
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Biochemical Response Rate
Baseline CA19-9
|
383 U/mL
Interval 2.0 to 1036.0
|
550 U/mL
Interval 1.0 to 1833.0
|
|
Biochemical Response Rate
Pre-Operative CA19-9
|
43 U/mL
Interval 1.0 to 109.0
|
53 U/mL
Interval 1.0 to 141.0
|
PRIMARY outcome
Timeframe: 4 - 8 weeks after neoadjuvant therapyPopulation: All subjects enrolled in the study were included in this analysis.
Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.
Outcome measures
| Measure |
Chemotherapy
n=3 Participants
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
n=7 Participants
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Radiographic Response Rate
Partial Response
|
1 participants
|
0 participants
|
|
Radiographic Response Rate
Stable Disease
|
2 participants
|
5 participants
|
|
Radiographic Response Rate
Progressive Disease
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: At the time of surgery after neoadjuvant therapyPopulation: Subjects who had a surgical resection of their primary tumor were included in this analysis.
Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.
Outcome measures
| Measure |
Chemotherapy
n=3 Participants
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
n=5 Participants
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Pathologic Downstaging and Margin Status
R0 Resection
|
3 participants
|
3 participants
|
|
Pathologic Downstaging and Margin Status
R1 Resection
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 90 days after surgeryEvaluate mortality in the first 90 days after surgery
Outcome measures
| Measure |
Chemotherapy
n=3 Participants
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy + ChemoRadiotherapy
n=5 Participants
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
90 Day Post-operative Mortality
Number of survival
|
3 participants
|
5 participants
|
|
90 Day Post-operative Mortality
Number of mortality
|
0 participants
|
0 participants
|
Adverse Events
Chemotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Chemotherapy and ChemoRadiotherapy
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy
n=3 participants at risk
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy and ChemoRadiotherapy
n=7 participants at risk
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
Other adverse events
| Measure |
Chemotherapy
n=3 participants at risk
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
|
Chemotherapy and ChemoRadiotherapy
n=7 participants at risk
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 5 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Alopeica
|
100.0%
3/3 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
3/3 • Number of events 4 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
71.4%
5/7 • Number of events 8 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Dsgeusia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
0.00%
0/7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Fatigue
|
100.0%
3/3 • Number of events 8 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
85.7%
6/7 • Number of events 17 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 6 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
0.00%
0/7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
0.00%
0/7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Hypokalemia
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Infections and infestations
Mucosal infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
0.00%
0/7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 4 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
0.00%
0/7 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Nervous system disorders
Nervous system disorders - Other, autonomic neuropathy
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 5 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
42.9%
3/7 • Number of events 5 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from informed consent to 30 days following the last dose of protocol therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place