Trial Outcomes & Findings for Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma (NCT NCT01844076)
NCT ID: NCT01844076
Last Updated: 2021-03-25
Results Overview
Establish the tolerability of both agents in combination when used at established clinical doses. The objective is to determine toxicities and adverse reactions of patients in each group with different dose levels to find the maximum tolerated dose (MTD).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
One year
Results posted on
2021-03-25
Participant Flow
Participant milestones
| Measure |
Phase I Level -2
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
7
|
|
Overall Study
COMPLETED
|
1
|
6
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Level -2
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Phase I Level -2
n=1 Participants
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
n=6 Participants
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
n=3 Participants
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
n=7 Participants
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
77 years
n=99 Participants
|
56.5 years
n=107 Participants
|
61 years
n=206 Participants
|
61 years
n=7 Participants
|
61 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
17 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: One yearEstablish the tolerability of both agents in combination when used at established clinical doses. The objective is to determine toxicities and adverse reactions of patients in each group with different dose levels to find the maximum tolerated dose (MTD).
Outcome measures
| Measure |
Phase I Level -2
n=1 Participants
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
n=6 Participants
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
n=3 Participants
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Phase I - Number of Participants Who Experienced Dose Limiting Toxicities and Adverse Reactions
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 2-3 yearsPopulation: Rate of response was analyzed for participants in phase II
Determine rate of response in patients receiving quinacrine in combination with capecitabine. Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) complete response (CR) is a disappearance of all target lesions, partial response (PR) is at least 30% decrease in the sum of diameters of target lesions, and overall response is the number of patients who experience a complete response or partial response.
Outcome measures
| Measure |
Phase I Level -2
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
n=7 Participants
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Phase II - Rate of Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-3 yearsPopulation: TTP was analyzed for participants enrolled in phase II
Determine time to progression from start of treatment in patients receiving quinacrine in combination with capecitabine. Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), progression is defined as a 20% increase in sum of target lesions, with at least a 5 mm absolute increase.
Outcome measures
| Measure |
Phase I Level -2
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
n=7 Participants
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Phase II - Time to Progression (TTP)
|
—
|
—
|
—
|
2.12 months
Interval 1.85 to 4.0
|
Adverse Events
Phase I Level -2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Level -1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase I Level 0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II
Serious events: 2 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase I Level -2
n=1 participants at risk
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
n=6 participants at risk
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
n=3 participants at risk
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
n=7 participants at risk
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Death
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Hsopitalization
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
Other adverse events
| Measure |
Phase I Level -2
n=1 participants at risk
Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.
Group 1: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle
|
Phase I Level -1
n=6 participants at risk
Group 2: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
Phase I Level 0
n=3 participants at risk
Group 3: capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
Phase II
n=7 participants at risk
Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.
Patients will receive capecitabine at a dose of 1000 mg/m\^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
Gastrointestinal disorders
Oral thrush
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Fatigue
|
100.0%
1/1 • 38 months
|
16.7%
1/6 • 38 months
|
66.7%
2/3 • 38 months
|
100.0%
7/7 • 38 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
66.7%
2/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
66.7%
2/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
100.0%
3/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
Investigations
Hyperbilirubinemia
|
100.0%
1/1 • 38 months
|
16.7%
1/6 • 38 months
|
66.7%
2/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
Elevated AST
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
White blood cell count decreased
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Investigations
Weight loss
|
100.0%
1/1 • 38 months
|
16.7%
1/6 • 38 months
|
100.0%
3/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Gastrointestinal disorders
Burping
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
100.0%
1/1 • 38 months
|
33.3%
2/6 • 38 months
|
33.3%
1/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
100.0%
1/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • 38 months
|
33.3%
2/6 • 38 months
|
100.0%
3/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • 38 months
|
66.7%
4/6 • 38 months
|
33.3%
1/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • 38 months
|
33.3%
2/6 • 38 months
|
66.7%
2/3 • 38 months
|
57.1%
4/7 • 38 months
|
|
Eye disorders
Eye disorder - other
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Chills
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 38 months
|
66.7%
4/6 • 38 months
|
100.0%
3/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 38 months
|
33.3%
2/6 • 38 months
|
66.7%
2/3 • 38 months
|
57.1%
4/7 • 38 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • 38 months
|
50.0%
3/6 • 38 months
|
66.7%
2/3 • 38 months
|
71.4%
5/7 • 38 months
|
|
General disorders
Polydipsia
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/1 • 38 months
|
50.0%
3/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Edema
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • 38 months
|
50.0%
3/6 • 38 months
|
66.7%
2/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Investigations
ANC decreased
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
ALT increased
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
AST increased
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
100.0%
3/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
66.7%
2/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Peeling skin
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • 38 months
|
33.3%
2/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
Increased ALP
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
66.7%
2/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
General disorders
Pain - biliary tube
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Loss of consciousness
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Jaundice
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Melena
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Investigations
Weight gain
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Sweats
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pulled muscle
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
General disorders
Numbness
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Eye disorders
Dry eyes
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • 38 months
|
33.3%
2/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Nervous system disorders
Diziness
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • 38 months
|
33.3%
2/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
General disorders
Burning sensation
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
General disorders
Small bowel obstruction
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
General disorders
Deep vein thrombosis
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
42.9%
3/7 • 38 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
General disorders
Nocturia
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
33.3%
1/3 • 38 months
|
28.6%
2/7 • 38 months
|
|
General disorders
Lip swelling
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
General disorders
Chest pain
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Vascular disorders
Bilateral pulmonary embolism
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
0.00%
0/3 • 38 months
|
0.00%
0/7 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Nervous system disorders
Cold sensitivity
|
0.00%
0/1 • 38 months
|
0.00%
0/6 • 38 months
|
0.00%
0/3 • 38 months
|
14.3%
1/7 • 38 months
|
|
Gastrointestinal disorders
Dry heaving
|
0.00%
0/1 • 38 months
|
16.7%
1/6 • 38 months
|
33.3%
1/3 • 38 months
|
0.00%
0/7 • 38 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place