Trial Outcomes & Findings for Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer (NCT NCT02720484)

NCT ID: NCT02720484

Last Updated: 2019-05-01

Results Overview

Overall Response Rate of nivolumab treatment for patients with metastatic adrenocortical carcinoma will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks: Complete Response (CR) = disappearance of all target lesions. Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions (should be confirmed 8 weeks after initial response otherwise considered unconfirmed PR). Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions..

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

From the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15.

Results posted on

2019-05-01

Participant Flow

The study opened for accrual on March 22 2016 with an accrual goal of up to 33 patients. The first patient started treatment March 30, 2016. Accrual was suspended on December 5, 2016 after the first 10 patients were enrolled for Interim Analysis. The study was closed permanently on May 24 2017 with no additional patients enrolled.

Participant milestones

Participant milestones
Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Treatment on Study STARTED	10
Treatment on Study Reached 1st Response/2 Cycles	7
Treatment on Study Treated Cycle 3	4
Treatment on Study COMPLETED	4
Treatment on Study NOT COMPLETED	6
Follow Up for 2 Years STARTED	7
Follow Up for 2 Years COMPLETED	1
Follow Up for 2 Years NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Treatment on Study Adverse Event	1
Treatment on Study Withdrawal by Subject	1
Treatment on Study Progressive Disease	4
Follow Up for 2 Years Withdrawal by Subject	1
Follow Up for 2 Years Death	3
Follow Up for 2 Years Lost to Follow-up	2

Baseline Characteristics

Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 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	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15.

Population: All patients that received one dose of nivolumab were evaluable for this objective.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Response Rate Complete Response	0 Participants
Overall Response Rate Unconfirmed Partial Response	1 Participants
Overall Response Rate Stable Disease	2 Participants
Overall Response Rate Progressive Disease	6 Participants
Overall Response Rate NE	1 Participants

SECONDARY outcome

Timeframe: From start of treatment and every 8 weeks/2 cycles until progressive disease or death. Median follow up of 4.5 months

Progression Free Survival (PFS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma is defined as the duration of time from start of treatment to time of documented progression or death, whichever comes first. It will measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Progression-free Survival (PFS)	1.8 Months Interval 0.1 to 4.3

SECONDARY outcome

Timeframe: At 3 months and 6 months from the initiation of treatment

Overall Survival (OS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma and will be defined as the duration of time from treatment initiation until death. OS will be assessed as the percentage of patients alive at 3 months and at 6 months from initiation of treatment on study.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Survival (OS) at 3 Months and 6 Months 3 months	79 percentage of patients alive Interval 14.0 to 90.0
Overall Survival (OS) at 3 Months and 6 Months 6 months	56 percentage of patients alive Interval 8.0 to 88.0

SECONDARY outcome

Timeframe: From treatment initiation, twice every Cycle (every 14 days) while on treatment, up to 12 weeks after final dose. Range of cycles completed 1-15 (1 Cycle=28 days)

Safety and tolerability profile of Nivolumab will be assessed by describing by number, frequency, and severity of Adverse Events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3. All AEs that were considered related to Nivolumab were collected and are shown below. Patients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted in each of those categories. Categories with no events are not shown. In general AEs will be graded according to the following: Grade 1 = Mild AE Grade 2= Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Toxicity of Nivolumab Rash Grade 1-2	3 participants
Toxicity of Nivolumab Nausea Grade 1-2	1 participants
Toxicity of Nivolumab Cough Grade 1-2	2 participants
Toxicity of Nivolumab Fatigue Grade 1-2	3 participants
Toxicity of Nivolumab ALT Increase Grade 1-2	1 participants
Toxicity of Nivolumab ALT Increase Grade 4	1 participants
Toxicity of Nivolumab AST Increase Grade 1-2	2 participants
Toxicity of Nivolumab AST Increase Grade 3	1 participants
Toxicity of Nivolumab Bilirubin Elevation Grade 1-2	2 participants
Toxicity of Nivolumab Hypokalemia Grade 3	1 participants
Toxicity of Nivolumab Dehydration Grade 3	1 participants
Toxicity of Nivolumab Mucositis Grade 1-2	3 participants
Toxicity of Nivolumab Tremor Grade 3	1 participants
Toxicity of Nivolumab Edema Grade 1-2	2 participants
Toxicity of Nivolumab Immune Pneumonitis Grade 3	1 participants
Toxicity of Nivolumab Immune Hepatitis Grade 3	1 participants

POST_HOC outcome

Timeframe: At 3 months and 6 months from the initiation of treatment

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=10 Participants Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Progression Free Survival Rate at 3 Months and 6 Months 3 Months	30 percentage of patients with PFS Interval 2.0 to 70.0
Progression Free Survival Rate at 3 Months and 6 Months 6 Months	20 percentage of patients with PFS Interval 0.0 to 62.0

Adverse Events

Treatment (Nivolumab)

Serious events: 7 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nivolumab) n=10 participants at risk Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Immune system disorders Immune Mediated Hepatitis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Dehydration	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Sepsis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Reproductive system and breast disorders Vaginal Hemorrhage	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Progressive Disease/Death	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Pleural Effusion	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Nervous system disorders Tremor	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Urinary Tract Infection	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Nervous system disorders Altered Mental Status	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Progressive Disease - Death	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15

Other adverse events

Other adverse events
Measure	Treatment (Nivolumab) n=10 participants at risk Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Blood and lymphatic system disorders Anemia	50.0% 5/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Cardiac disorders Atrial Flutter	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Cardiac disorders Sinus Tachycardia	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Endocrine disorders Adrenal Insufficiency	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Endocrine disorders Hypothyroidism	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Eye disorders Blurred Vision	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Abdominal Pain	30.0% 3/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Ascites	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Constipation	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Cheilitis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Anal Mucositis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Oral Mucositis	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Nausea	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Vomiting	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Odynophagia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Gastrointestinal disorders Blisters on lips	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Edema in limbs	40.0% 4/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Fatigue	40.0% 4/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Fever	30.0% 3/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Infusion Related Reaction	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
General disorders Tachypnea	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Immune system disorders Immune Mediated Hepatitis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Mucosal Infection	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Otitis Media	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Upper Respiratory Infection	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Vaginal Infection	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Infections and infestations Oral Candidiasis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Alanine Aminotransferase Increased	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Alkaline Phosphatase Increased	30.0% 3/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Aspartate Aminotransferase Increased	50.0% 5/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Blood Bilirubin Increased	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Creatinine Increased	30.0% 3/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations INR Increased	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Lymphocyte Count Decreased	40.0% 4/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Lymphocyte Count Increased	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Neutrophil Count Decreased	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations Weight Loss	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Investigations White Blood Cell Decreased	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Anorexia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hypercalcemia	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hyperglycemia	90.0% 9/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hyperkalemia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hypoalbuminemia	60.0% 6/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hypokalemia	60.0% 6/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Metabolism and nutrition disorders Hyponatremia	50.0% 5/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Musculoskeletal and connective tissue disorders Back Pain	20.0% 2/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Musculoskeletal and connective tissue disorders Trunk Muscle Weakness	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Musculoskeletal and connective tissue disorders Right Knee Stiffness	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Nervous system disorders Hypersomnia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Nervous system disorders Paresthesia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Nervous system disorders Tremor	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Psychiatric disorders Anxiety	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Psychiatric disorders Depression	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Renal and urinary disorders Acute Kidney Injury	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Renal and urinary disorders Chronic Kidney Disease	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Renal and urinary disorders Urinary Frequency	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Reproductive system and breast disorders Gynecomastia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Reproductive system and breast disorders Vaginal Hemorrhage	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Pharyngeal Mucositis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Postnasal Drip	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Sneezing	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Sore Throat	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Skin and subcutaneous tissue disorders Maculopapular Rash	30.0% 3/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	10.0% 1/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15
Vascular disorders Hypertension	60.0% 6/10 • Adverse Events were collected for the study over approximately 1 and a half years with patients being assessed for AEs from the time of treatment initiation, at the beginning of each cycle, through 30 days post last treatment. One cycle equals 28 days and the range of cycles attempted or completed by patients was 1 to 15

Additional Information

Devalingam Mahalingam

Northwestern University

Phone: 312.472.0564

Email: [email protected];

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place