Trial Outcomes & Findings for Pembrolizumab and Capecitabine in Treating Patients With Locally Advanced or Metastatic Triple Negative or Hormone-Refractory Breast Cancer That Cannot Be Removed by Surgery (NCT NCT03044730)

Last Updated: 2020-07-13

Results Overview

To evaluate the median Progression-Free Survival (PFS) for participants receiving pembrolizumab with capecitabine for the treatment of locally advanced or metastatic TNBC and hormone-refractory MBC. PFS is defined as the length of time during and after the treatment that a patient does not experience progression. Progressive Disease (PD) as defined per RECIST 1.1 is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). PFS was analyzed using a Kaplan-Meier curve. For PFS, assumptions were that the addition of pembrolizumab would increase PFS to 5 months compared to historical control of 3 months.

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Approximately 20 months

Results posted on

2020-07-13

Participant Flow

The study opened for enrollment on May 25th, 2017 with an accrual goal of 30 patients. The first patient started treatment on May 30th, 2017. The study closed permanently to further enrollment on March 12th, 2018 as the accrual goal was met.

Participant milestones

Participant milestones
Measure	Treatment: Pembrolizumab + Capecitabine This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
3 Cycles of Pembro + Capecitab STARTED	30
3 Cycles of Pembro + Capecitab Attempted Cycle 1	30
3 Cycles of Pembro + Capecitab Attempted Cycle 2	28
3 Cycles of Pembro + Capecitab Attempted Cycle 3	26
3 Cycles of Pembro + Capecitab COMPLETED	26
3 Cycles of Pembro + Capecitab NOT COMPLETED	4
Cycles 4 and Beyond STARTED	26
Cycles 4 and Beyond Assessed for Cycle 4	26
Cycles 4 and Beyond Started Cycle 4	20
Cycles 4 and Beyond Went on to Cycle 5 and Beyond	16
Cycles 4 and Beyond COMPLETED	16
Cycles 4 and Beyond NOT COMPLETED	10
On Follow-up for 2 Years STARTED	29
On Follow-up for 2 Years COMPLETED	4
On Follow-up for 2 Years NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment: Pembrolizumab + Capecitabine This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
3 Cycles of Pembro + Capecitab Progressive Disease	1
3 Cycles of Pembro + Capecitab Patient non-compliant with capecitabine	1
3 Cycles of Pembro + Capecitab Death	1
3 Cycles of Pembro + Capecitab Adverse Event	1
Cycles 4 and Beyond Progressive Disease	9
Cycles 4 and Beyond Adverse Event	1
On Follow-up for 2 Years Still in follow-up	7
On Follow-up for 2 Years Lost to Follow-up	1
On Follow-up for 2 Years Death	17

Baseline Characteristics

Pembrolizumab and Capecitabine in Treating Patients With Locally Advanced or Metastatic Triple Negative or Hormone-Refractory Breast Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment: Pembrolizumab + Capecitabine n=30 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=39 Participants
Age, Categorical >=65 years	2 Participants n=39 Participants
Sex: Female, Male Female	30 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	3 Participants n=39 Participants
Race (NIH/OMB) White	25 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=39 Participants
Region of Enrollment United States	30 participants n=39 Participants
Triple Negative vs Hormone Receptor Positive MBC Triple Negative MBC	16 Participants n=39 Participants
Triple Negative vs Hormone Receptor Positive MBC Hormone Receptor Positive MBC	14 Participants n=39 Participants

PRIMARY outcome

Timeframe: Approximately 20 months

Population: One patient was not evaluable due to non-compliance with capecitabine. Three patients were not evaluable because they did not reach 3 cycles of treatment (per Protocol).

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=26 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
Median PFS (Median Progression-Free Survival)	4.13 months Interval 2.75 to 12.7

SECONDARY outcome

Timeframe: Up to 9 Cycles (1 cycle = 21 days)

Population: One patient was not evaluable due to non-compliance with capecitabine. Three patients were not evaluable because they did not have 3 cycles of treatment (as required per protocol to be evaluable for efficacy endpoints).

The ORR is the percentage of patients whose cancer shrinks or disappears after treatment. Objective response rate was calculated based on the number of patients who had a Complete Response (CR) or a Partial Response (PR). CR and PR were measured according to RECIST v. 1.1 guidelines: * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=26 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
Objective Response Rate (ORR) Complete Response	0 participants
Objective Response Rate (ORR) Partial Response	4 participants

SECONDARY outcome

Timeframe: Up to 2 years

Determine the safety and tolerability of the combination of pembrolizumab and Capecitabine by evaluating the incidence of adverse events. All adverse events will be assessed using the National Cancer Institute Common Terminology Criteria 4.03 criteria (NCI CTCAE 4.03 criteria).

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Up to 14 cycles (1 cycle= 21 days)

Population: One patient was not evaluable due to non-compliance with capecitabine. Patients who received at least one dose of capecitabine and pembrolizumab were included in the analysis.

To evaluate the clinical benefit rate (CBR) per RECIST v. 1.1. CBR is the rate of participants with complete response (CR), partial response (PR) or stable disease (SD) \> 6 months. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=29 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
Clinical Benefit Rate (CBR)	28 percentage of participants

POST_HOC outcome

Timeframe: Up to 1 year after starting treatment

Population: One patient was excluded from the analysis due to patient non-compliance with capecitabine. Patients who received at least 1 dose of pembrolizumab and capecitabine were included in the analysis.

To evaluate the 1-year progression free survival (PFS) rate per RECIST v. 1.1. PFS is defined as the length of time during and after the treatment that a patient does not experience progression. Progressive Disease (PD) as defined per RECIST 1.1 is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). PFS was analyzed using a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=29 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
1-year Progression Free Survival (PFS) Rate	20.7 percentage of participants

POST_HOC outcome

Timeframe: Approximately 20 months

Population: One patient was not evaluable due to non-compliance with capecitabine. Patients who received at least one dose of pembrolizumab with capecitabine were included in the analysis.

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=29 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
Median PFS (Median Progression-Free Survival)	4.0 months Interval 2.0 to 6.4

POST_HOC outcome

Timeframe: Up to 9 Cycles (1 cycle = 21 days)

Population: One patient was not evaluable due to non-compliance with capecitabine. The analysis included all patients who received at least one dose of capecitabine and pembrolizumab.

The ORR is the percentage of patients whose cancer shrinks or disappears after treatment. Objective response rate was calculated based on percentage of patients who had a Complete Response (CR) or a Partial Response (PR). CR and PR were measured according to RECIST v. 1.1 guidelines: * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Treatment: Pembrolizumab + Capecitabine n=29 Participants This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
Objective Response Rate (ORR)	14 percentage of participants

Adverse Events

Treatment: Pembrolizumab + Capecitabine

Serious events: 19 serious events

Other events: 30 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Treatment: Pembrolizumab + Capecitabine n=30 participants at risk This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
Psychiatric disorders Delerium	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Seizure	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression	33.3% 10/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Abdominal Pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Pneumonistis	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Blood bilirubin increased	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.

Other adverse events

Other adverse events
Measure	Treatment: Pembrolizumab + Capecitabine n=30 participants at risk This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
Blood and lymphatic system disorders Anemia	16.7% 5/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Palpitations	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Sinus tachycardia	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Endocrine disorders Endocrine disorders - Other, specify	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Endocrine disorders Hypothyroidism	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Eye disorders Blurred vision	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Eye disorders Dry eye	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Eye disorders Eye disorders - Other, specify	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Eye disorders Photophobia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Eye disorders Watering eyes	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Abdominal distension	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Abdominal pain	30.0% 9/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Ascites	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Bloating	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Colitis	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Constipation	33.3% 10/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Diarrhea	50.0% 15/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Esophagitis	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Lip pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Mucositis oral	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Nausea	43.3% 13/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Rectal pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Stomach pain	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Vomiting	26.7% 8/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Chills	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Edema limbs	20.0% 6/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Fatigue	43.3% 13/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Fever	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Flu like symptoms	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Gait disturbance	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders General disorders and administration site conditions - Other, specify	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Non-cardiac chest pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Hepatobiliary disorders Gallbladder obstruction	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Hepatobiliary disorders Hepatic failure	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Bronchial infection	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Lip infection	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Papulopustular rash	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Sinusitis	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Upper respiratory infection	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Urinary tract infection	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Vaginal infection	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Wound infection	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Injury, poisoning and procedural complications Spinal fracture	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Activated partial thromboplastin time prolonged	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Alanine aminotransferase increased	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Alkaline phosphatase increased	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Aspartate aminotransferase increased	33.3% 10/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Blood bilirubin increased	20.0% 6/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Creatinine increased	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Fibrinogen decreased	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations INR increased	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Investigations - Other, specify	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Lymphocyte count decreased	26.7% 8/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Neutrophil count decreased	16.7% 5/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Platelet count decreased	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Weight loss	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations White blood cell decreased	16.7% 5/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Anorexia	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Dehydration	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypercalcemia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyperglycemia	36.7% 11/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypermagnesemia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypoalbuminemia	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypocalcemia	20.0% 6/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypoglycemia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypokalemia	36.7% 11/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypomagnesemia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyponatremia	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypophosphatemia	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Back pain	16.7% 5/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Bone pain	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Pain in extremity	26.7% 8/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Dizziness	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Headache	30.0% 9/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Intracranial hemorrhage	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Nervous system disorders - Other, specify	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Neuralgia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Paresthesia	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Peripheral sensory neuropathy	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Seizure	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Tremor	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Anxiety	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Confusion	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Delirium	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Hallucinations	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Insomnia	16.7% 5/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Acute kidney injury	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Urinary urgency	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Reproductive system and breast disorders Pelvic pain	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Reproductive system and breast disorders Vaginal discharge	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Cough	23.3% 7/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Productive cough	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Sneezing	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Sore throat	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Dry skin	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Erythema multiforme	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	46.7% 14/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Rash acneiform	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.3% 4/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.0% 6/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Skin ulceration	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hematoma	0.00% 0/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hot flashes	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hypertension	10.0% 3/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hypotension	6.7% 2/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Thromboembolic event	3.3% 1/30 • Patients on study may continue treatment until progression or unacceptable toxicity. AEs currently collected for up to 27 cycles for any patient where one cycle equals 21 days. Adverse event data shown below includes all events collected and available up until March 30, 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.

Additional Information

William John Gradishar, MD, FACP, FASCO

Northwestern University, Feinberg School of Medicine

Phone: (312) 695-4541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place