Trial Outcomes & Findings for Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC) (NCT NCT03111732)

Last Updated: 2021-12-03

Results Overview

Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

5 Months

Results posted on

2021-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
Overall Study STARTED	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
Overall Study Enrolled in different study	1
Overall Study Progressive disease	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	64.32 years STANDARD_DEVIATION 8.87 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 Months

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely Unlikely related to drug.	Possibly Possibly related to drug.	Probably Probably related to drug.	Definitely Definitely related to drug.
Progression Free Survival (PFS)	4.54 Months Interval 2.5 to 9.6	—	—	—	—

SECONDARY outcome

Timeframe: Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks.

Number of participants obtaining CR and PR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of all evaluable patients. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions,taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely Unlikely related to drug.	Possibly Possibly related to drug.	Probably Probably related to drug.	Definitely Definitely related to drug.
Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR) Complete Response	0 Participants	—	—	—	—
Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR) Partial Response	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Death, approximately 48 weeks after stopping therapy.

Median amount of time subject survives after therapy.

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely Unlikely related to drug.	Possibly Possibly related to drug.	Probably Probably related to drug.	Definitely Definitely related to drug.
Overall Survival	43 Weeks Interval 22.0 to 66.0	—	—	—	—

SECONDARY outcome

Timeframe: 30 Days After Enrollment

Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely n=11 Participants Unlikely related to drug.	Possibly n=11 Participants Possibly related to drug.	Probably n=11 Participants Probably related to drug.	Definitely n=11 Participants Definitely related to drug.
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab Grade 1	9 Participants	11 Participants	10 Participants	3 Participants	0 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab Grade 2	7 Participants	10 Participants	8 Participants	3 Participants	0 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab Grade 3	3 Participants	7 Participants	8 Participants	1 Participants	0 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab Grade 4	0 Participants	3 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 Days After Enrollment

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely n=11 Participants Unlikely related to drug.	Possibly n=11 Participants Possibly related to drug.	Probably n=11 Participants Probably related to drug.	Definitely n=11 Participants Definitely related to drug.
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin Grade 1	9 Participants	11 Participants	11 Participants	7 Participants	4 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin Grade 2	6 Participants	10 Participants	9 Participants	5 Participants	2 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin Grade 3	3 Participants	6 Participants	8 Participants	2 Participants	0 Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin Grade 4	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 Days After Enrollment

Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, and probably related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely n=11 Participants Unlikely related to drug.	Possibly n=11 Participants Possibly related to drug.	Probably n=11 Participants Probably related to drug.	Definitely n=11 Participants Definitely related to drug.
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine Grade 1	9 Participants	11 Participants	11 Participants	6 Participants	0 Participants
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine Grade 2	7 Participants	9 Participants	9 Participants	4 Participants	0 Participants
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine Grade 3	3 Participants	6 Participants	7 Participants	2 Participants	0 Participants
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine Grade 4	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 38 months and 25 days.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 Participants Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6	Unlikely Unlikely related to drug.	Possibly Possibly related to drug.	Probably Probably related to drug.	Definitely Definitely related to drug.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	11 Participants	—	—	—	—

Adverse Events

1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine

Serious events: 4 serious events

Other events: 11 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 participants at risk Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
Gastrointestinal disorders Abdominal distension	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Ascites	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Bloating	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Colitis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Diarrhea	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Infections and infestations - Other, unknown origin	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.

Other adverse events

Other adverse events
Measure	1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine n=11 participants at risk Pembrolizumab plus Oxaliplatin plus Capecitabine Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6 Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
Gastrointestinal disorders Abdominal distension	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Abdominal pain	54.5% 6/11 • Number of events 8 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Activated partial thromboplastin time prolonged	45.5% 5/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Alanine aminotransferase increased	81.8% 9/11 • Number of events 13 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Alkaline phosphatase increased	63.6% 7/11 • Number of events 12 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Blood and lymphatic system disorders Anemia	72.7% 8/11 • Number of events 25 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Anorexia	36.4% 4/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Psychiatric disorders Anxiety	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Ascites	45.5% 5/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Aspartate aminotransferase increased	81.8% 9/11 • Number of events 18 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Immune system disorders Autoimmune disorder	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Bloating	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Blood bilirubin increased	54.5% 6/11 • Number of events 12 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Eye disorders Blurred vision	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Chills	45.5% 5/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Colitis	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Constipation	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Creatinine increased	36.4% 4/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Dehydration	45.5% 5/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Psychiatric disorders Depression	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Diarrhea	54.5% 6/11 • Number of events 17 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Nervous system disorders Dizziness	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Eye disorders Dry eye	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Dry mouth	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Nervous system disorders Dysesthesia	54.5% 6/11 • Number of events 18 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Edema limbs	18.2% 2/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Eye disorders Eye disorders - Other, Conjunctival hemorrhage	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Fatigue	54.5% 6/11 • Number of events 10 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Fever	45.5% 5/11 • Number of events 9 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Flu like symptoms	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Gastritis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Gastrointestinal disorders - Other, Cramping	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Gastrointestinal disorders - Other, indigestion	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Nervous system disorders Headache	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Hemorrhoids	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypercalcemia	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hyperglycemia	54.5% 6/11 • Number of events 10 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypermagnesemia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypernatremia	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hyperuricemia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypoalbuminemia	72.7% 8/11 • Number of events 19 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypocalcemia	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypokalemia	36.4% 4/11 • Number of events 8 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypomagnesemia	36.4% 4/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hyponatremia	45.5% 5/11 • Number of events 9 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Metabolism and nutrition disorders Hypophosphatemia	54.5% 6/11 • Number of events 12 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Immune system disorders Immune system disorders - Other, Adrenal insufficiency	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Infections and infestations - Other, Herpes labialis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Infections and infestations - Other, Mucositis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Infections and infestations - Other, Thrush - tongue, mucosal infection	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Infections and infestations Infections and infestations - Other, Erythema, swelling under bilat. Eyes	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Lipase increased	9.1% 1/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Lymphocyte count decreased	100.0% 11/11 • Number of events 51 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Malaise	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Nausea	45.5% 5/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Neutrophil count decreased	45.5% 5/11 • Number of events 13 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Oral dysesthesia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Oral pain	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
General disorders Pain	36.4% 4/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Nervous system disorders Paresthesia	36.4% 4/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Nervous system disorders Peripheral sensory neuropathy	81.8% 9/11 • Number of events 17 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Platelet count decreased	81.8% 9/11 • Number of events 20 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Hepatobiliary disorders Portal vein thrombosis	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Pruritus	36.4% 4/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Serum amylase increased	45.5% 5/11 • Number of events 13 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Cardiac disorders Sinus tachycardia	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Thrush- mouth	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema, swelling under bilat. Eyes	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Rash, nose	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Skin lesion- cyst	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Swelling- lower leg	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, brittle nails	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, night sweats	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, buttocks	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, swelling - left foot	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Renal and urinary disorders Urinary retention	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Gastrointestinal disorders Vomiting	36.4% 4/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations Weight loss	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months and 25 days.
Investigations White blood cell decreased	72.7% 8/11 • Number of events 28 • Date treatment consent signed to date off study, approximately 38 months and 25 days.

Additional Information

Dr. Tim F. Greten

National Cancer Institute

Phone: 240-760-6114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place