Trial Outcomes & Findings for Pembrolizumab, Capecitabine, and Bevacizumab for Treating Colorectal Cancer (NCT NCT03396926)
NCT ID: NCT03396926
Last Updated: 2025-02-28
Results Overview
A DLT evaluation of the first 6 participants will be conducted to confirm the safety of administering pembrolizumab at 200 mg (flat dosing) every three weeks with capecitabine and bevacizumab and include all participants in the safety lead in cohort who received at least 1 dose of study treatment. At least one laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment is required for inclusion in the analysis including a baseline measure. Dose-limiting toxicity (DLT) must be clinically-significant toxicities which are at least possibly treatment-related per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Up to 1 cycle (each cycle is 21 days)
Results posted on
2025-02-28
Participant Flow
Participants in safety lead in cohort will be included in expansion cohort as All Subjects as Treated (ASaT) population. ASaT population will be used for analysis of objective response (ORR), disease control (DCR), progression-free survival (PFS) and overall survival (OS) and consist of participants who received at least one dose of study treatment (200mg pembrolizumab, 7.5mg/kg bevacizumab and 1000mg/m2 capecitabine). Participants ineligible for safety analysis will be replaced.
Participant milestones
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Participants received 200 mg pembrolizumab IV over 30 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 1000 mg/m2 capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Participants received 200 mg pembrolizumab IV over 30 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 1000 mg/m2 capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Safety Lead In Cohort
STARTED
|
7
|
0
|
|
Safety Lead In Cohort
COMPLETED
|
6
|
0
|
|
Safety Lead In Cohort
NOT COMPLETED
|
1
|
0
|
|
Expansion Cohort
STARTED
|
7
|
37
|
|
Expansion Cohort
COMPLETED
|
7
|
33
|
|
Expansion Cohort
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Participants received 200 mg pembrolizumab IV over 30 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 1000 mg/m2 capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Participants received 200 mg pembrolizumab IV over 30 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 1000 mg/m2 capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Expansion Cohort
Participants did not complete follow-up scan required for disease response outcomes
|
0
|
4
|
Baseline Characteristics
Pembrolizumab, Capecitabine, and Bevacizumab for Treating Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=7 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=37 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years old
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
37 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 cycle (each cycle is 21 days)A DLT evaluation of the first 6 participants will be conducted to confirm the safety of administering pembrolizumab at 200 mg (flat dosing) every three weeks with capecitabine and bevacizumab and include all participants in the safety lead in cohort who received at least 1 dose of study treatment. At least one laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment is required for inclusion in the analysis including a baseline measure. Dose-limiting toxicity (DLT) must be clinically-significant toxicities which are at least possibly treatment-related per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=6 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Participants With Treatment-related, Dose-limiting Toxicities (DLT) (Safety Lead-In Cohort)
|
0.33 proportion of participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsORR is defined as the percentage of the participants in the ASaT population who have a confirmed complete response (CR) or a partial response (PR) (Overall Response (OR) = CR + PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on Computerized Tomography (CT) or magnetic resonance imaging or (MRI) imaging if a CT cannot be obtained. The ORR and 95% confidence interval will be provided using exact binomial method proposed by Clopper and Pearson (1934).
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=40 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate (ORR)
|
5 percentage of participants
Interval 0.6 to 16.9
|
SECONDARY outcome
Timeframe: Up to 4 yearsDCR is defined as the percentage of participants who have achieved confirmed CR or PR or have demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression assessed by RECIST and immune-related RECIST (irRECIST). The percentage of participants and 95% confidence interval, will be provided using exact binomial method proposed by Clopper and Pearson (1934).
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=40 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease Control Rate (DCR)
|
25 percentage of participants
Interval 16.7 to 41.2
|
SECONDARY outcome
Timeframe: Up to 4 yearsDuration of response is defined as the time from first documented evidence of CR or PR assessed by RECIST and irRECIST until disease progression or death due to any cause, whichever occurs first. Kaplan-Meier (KM) curves and median estimates from will be reported
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=40 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Duration of Response (DOR)
|
13.5 months
Interval 12.3 to
The upper range of the confidence interval was calculated to be infinity
|
SECONDARY outcome
Timeframe: Up to 4 yearsOS is defined as the time from first day of study treatment to death due to any cause. Subjects without documented death at the time of the final analysis will be censored at the date of the last follow-up. KM curves and median estimates from the KM curves will be provided as appropriate.
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=40 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Overall Survival (OS)
|
10.1 months
Interval 8.52 to 15.2
|
SECONDARY outcome
Timeframe: Up to 4 yearsPFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Median estimates in months and the 95% confidence interval will be reported.
Outcome measures
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=40 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
4.29 months
Interval 3.68 to 6.05
|
Adverse Events
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
Serious events: 11 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=7 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=37 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Number of events 7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Colonic perforation
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 3 • Up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Urinary tract pain
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
Other adverse events
| Measure |
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=7 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice a day (BID) on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
n=37 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • Number of events 6 • Up to 4 years
|
48.6%
18/37 • Number of events 26 • Up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 13 • Up to 4 years
|
35.1%
13/37 • Number of events 17 • Up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
40.5%
15/37 • Number of events 17 • Up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
4/7 • Number of events 7 • Up to 4 years
|
27.0%
10/37 • Number of events 13 • Up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
57.1%
4/7 • Number of events 12 • Up to 4 years
|
27.0%
10/37 • Number of events 17 • Up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 8 • Up to 4 years
|
27.0%
10/37 • Number of events 16 • Up to 4 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
10.8%
4/37 • Number of events 4 • Up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
13.5%
5/37 • Number of events 5 • Up to 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Up to 4 years
|
10.8%
4/37 • Number of events 5 • Up to 4 years
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Gastrointestinal disorders
Cheilitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 3 • Up to 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 4 • Up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 11 • Up to 4 years
|
64.9%
24/37 • Number of events 29 • Up to 4 years
|
|
General disorders
Non-cardiac chest pain
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
21.6%
8/37 • Number of events 10 • Up to 4 years
|
|
General disorders
Fever
|
42.9%
3/7 • Number of events 5 • Up to 4 years
|
13.5%
5/37 • Number of events 9 • Up to 4 years
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 3 • Up to 4 years
|
13.5%
5/37 • Number of events 6 • Up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
10.8%
4/37 • Number of events 4 • Up to 4 years
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
10.8%
4/37 • Number of events 5 • Up to 4 years
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
General disorders
Malaise
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
100.0%
7/7 • Number of events 20 • Up to 4 years
|
54.1%
20/37 • Number of events 61 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
71.4%
5/7 • Number of events 9 • Up to 4 years
|
27.0%
10/37 • Number of events 11 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
42.9%
3/7 • Number of events 3 • Up to 4 years
|
27.0%
10/37 • Number of events 12 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
71.4%
5/7 • Number of events 12 • Up to 4 years
|
16.2%
6/37 • Number of events 9 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Number of events 3 • Up to 4 years
|
21.6%
8/37 • Number of events 11 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
1/7 • Number of events 3 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/7 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Investigations
Blood bilirubin increased
|
42.9%
3/7 • Number of events 8 • Up to 4 years
|
37.8%
14/37 • Number of events 30 • Up to 4 years
|
|
Investigations
Weight loss
|
57.1%
4/7 • Number of events 12 • Up to 4 years
|
24.3%
9/37 • Number of events 16 • Up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 3 • Up to 4 years
|
18.9%
7/37 • Number of events 8 • Up to 4 years
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
18.9%
7/37 • Number of events 18 • Up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to 4 years
|
5.4%
2/37 • Number of events 5 • Up to 4 years
|
|
Investigations
Weight gain
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Investigations
Lipase increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 3 • Up to 4 years
|
|
Investigations
Serum amylase increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Number of events 4 • Up to 4 years
|
24.3%
9/37 • Number of events 16 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
18.9%
7/37 • Number of events 13 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
16.2%
6/37 • Number of events 11 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
8.1%
3/37 • Number of events 5 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
28.6%
2/7 • Number of events 6 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 6 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/7 • Up to 4 years
|
5.4%
2/37 • Number of events 3 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
18.9%
7/37 • Number of events 8 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
18.9%
7/37 • Number of events 7 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
10.8%
4/37 • Number of events 5 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
42.9%
3/7 • Number of events 3 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Up to 4 years
|
10.8%
4/37 • Number of events 4 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Number of events 10 • Up to 4 years
|
35.1%
13/37 • Number of events 15 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
4/7 • Number of events 8 • Up to 4 years
|
16.2%
6/37 • Number of events 7 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Up to 4 years
|
10.8%
4/37 • Number of events 5 • Up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 9 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Renal and urinary disorders
Proteinuria
|
28.6%
2/7 • Number of events 3 • Up to 4 years
|
21.6%
8/37 • Number of events 14 • Up to 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 4 • Up to 4 years
|
|
Renal and urinary disorders
Urine discoloration
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/7 • Up to 4 years
|
10.8%
4/37 • Number of events 4 • Up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Abdominal infection
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Infections and infestations
Penile infection
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 7 • Up to 4 years
|
18.9%
7/37 • Number of events 8 • Up to 4 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 8 • Up to 4 years
|
13.5%
5/37 • Number of events 6 • Up to 4 years
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 4 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Nervous system disorders
Tremor
|
28.6%
2/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 4 • Up to 4 years
|
13.5%
5/37 • Number of events 11 • Up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Vascular disorders
Vasculitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Psychiatric disorders
Restlessness
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
2/7 • Number of events 4 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Endocrine disorders
Adrenal insufficiency
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 6 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
28.6%
2/7 • Number of events 3 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
8.1%
3/37 • Number of events 3 • Up to 4 years
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
14.3%
1/7 • Number of events 2 • Up to 4 years
|
0.00%
0/37 • Up to 4 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Immune system disorders
Allergic reaction
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
5.4%
2/37 • Number of events 2 • Up to 4 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 2 • Up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Up to 4 years
|
2.7%
1/37 • Number of events 1 • Up to 4 years
|
Additional Information
Dr.Chloe Atreya, MD, PhD
University of California, San Francisco
Phone: (415) 353-9888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place