Trial Outcomes & Findings for Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma (NCT NCT02032810)
NCT ID: NCT02032810
Last Updated: 2023-01-20
Results Overview
MTD and recommended Phase 2 dose (RP2D) of panobinostat (PAN), administered in combination with ipilimumab (IPI) in participants with unresectable Stage III or Stage IV melanoma. The goal is to enroll up to 36 patients for determination of the MTD, but will be successfully concluded earlier if 12 patients are accrued at the dose determined to be the MTD, with 3 dose limiting toxicities (DLTs). All participants who receive study any drug therapy will be evaluated for safety. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests. Triplicate 12-lead electrocardiograms (ECGs) will be collected prior to dosing on Day 1 of induction cycle 1. MTD of PAN in milligrams (mg), with IPI at 3 mg/kg.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2023-01-20
Participant Flow
Participants were enrolled at Moffitt Cancer Center, November 2014 through November 2016.
Participant milestones
| Measure |
Panobinostat 5 mg
Participants who received 5 mg of Panobinostat along with 3 mg Ipilimumab
|
Panobinostat 10 mg
Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
|
Overall Study
COMPLETED
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma
Baseline characteristics by cohort
| Measure |
Panobinostat 5 mg
n=6 Participants
Participants who received 5 mg of Panobinostat along with 3 mg Ipililumab
|
Panobinostat 10 mg
n=11 Participants
Participants who received 10 mg of Panobinostat along with 3 mg Ipililumab
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
MTD and recommended Phase 2 dose (RP2D) of panobinostat (PAN), administered in combination with ipilimumab (IPI) in participants with unresectable Stage III or Stage IV melanoma. The goal is to enroll up to 36 patients for determination of the MTD, but will be successfully concluded earlier if 12 patients are accrued at the dose determined to be the MTD, with 3 dose limiting toxicities (DLTs). All participants who receive study any drug therapy will be evaluated for safety. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests. Triplicate 12-lead electrocardiograms (ECGs) will be collected prior to dosing on Day 1 of induction cycle 1. MTD of PAN in milligrams (mg), with IPI at 3 mg/kg.
Outcome measures
| Measure |
Dose Escalation of Panobinostat, Plus Ipilimumab
n=17 Participants
Eligible participants with unresectable stage 3/4 MEL, up to 3 prior lines of therapy, and adequate laboratory values were treated with oral PAN 5 mg thrice weekly (TIW) plus IPI at 3 mg/kg IV every 3 weeks X 4 doses, followed by maintenance PAN until progression or intolerance. Using a modified Ji design, PAN dose escalation by 5 mg was planned in 3-12 participant cohorts up to a maximum dose of 20 mg TIW, without intra-participant dose escalation. Dose limiting toxicity (DLT) was assessed up to day 84 from start of therapy.
|
Panobinostat 10 mg
Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
|
|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
5 mg
|
—
|
SECONDARY outcome
Timeframe: Up to 36 monthsTumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Criteria (irRC). RECIST: Best overall response from start of treatment until disease progression/recurrence. Immune-related Complete Response (irCR): Complete disappearance of all tumor lesions for at least 4 weeks from date of documentation of irCR. Immune-related Partial Response (irPR): Sum of the products of the 2 largest perpendicular diameters of all index lesions, measured and captured as the Sum of Product of Diameters (SPD) baseline. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Immune-related Progressive Disease (irPD): At least a 25% increase in the SPD of all index lesions and new measurable lesions (irSPD) over the nadir SPD calculated for the index lesions.
Outcome measures
| Measure |
Dose Escalation of Panobinostat, Plus Ipilimumab
n=6 Participants
Eligible participants with unresectable stage 3/4 MEL, up to 3 prior lines of therapy, and adequate laboratory values were treated with oral PAN 5 mg thrice weekly (TIW) plus IPI at 3 mg/kg IV every 3 weeks X 4 doses, followed by maintenance PAN until progression or intolerance. Using a modified Ji design, PAN dose escalation by 5 mg was planned in 3-12 participant cohorts up to a maximum dose of 20 mg TIW, without intra-participant dose escalation. Dose limiting toxicity (DLT) was assessed up to day 84 from start of therapy.
|
Panobinostat 10 mg
n=11 Participants
Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
|
|---|---|---|
|
Immune Related Overall Response Rate (ORR)
Complete Response
|
0 Participants
|
0 Participants
|
|
Immune Related Overall Response Rate (ORR)
Stable Disease
|
3 Participants
|
3 Participants
|
|
Immune Related Overall Response Rate (ORR)
Partial Response
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsProgression Free Survival (PFS): is defined for each participant as the time from first dosing to the first observation of disease progression or death due to any cause. If a subject has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. PFS will be calculated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Escalation of Panobinostat, Plus Ipilimumab
n=6 Participants
Eligible participants with unresectable stage 3/4 MEL, up to 3 prior lines of therapy, and adequate laboratory values were treated with oral PAN 5 mg thrice weekly (TIW) plus IPI at 3 mg/kg IV every 3 weeks X 4 doses, followed by maintenance PAN until progression or intolerance. Using a modified Ji design, PAN dose escalation by 5 mg was planned in 3-12 participant cohorts up to a maximum dose of 20 mg TIW, without intra-participant dose escalation. Dose limiting toxicity (DLT) was assessed up to day 84 from start of therapy.
|
Panobinostat 10 mg
n=11 Participants
Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.19 Months
Interval 1.68 to
The high end of the range was not reached at time of analysis.
|
1.81 Months
Interval 1.45 to
The high end of the range was not reached at time of analysis.
|
SECONDARY outcome
Timeframe: 36 monthsOverall survival: The time from randomization until death from any cause.
Outcome measures
| Measure |
Dose Escalation of Panobinostat, Plus Ipilimumab
n=6 Participants
Eligible participants with unresectable stage 3/4 MEL, up to 3 prior lines of therapy, and adequate laboratory values were treated with oral PAN 5 mg thrice weekly (TIW) plus IPI at 3 mg/kg IV every 3 weeks X 4 doses, followed by maintenance PAN until progression or intolerance. Using a modified Ji design, PAN dose escalation by 5 mg was planned in 3-12 participant cohorts up to a maximum dose of 20 mg TIW, without intra-participant dose escalation. Dose limiting toxicity (DLT) was assessed up to day 84 from start of therapy.
|
Panobinostat 10 mg
n=11 Participants
Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
|
|---|---|---|
|
Overall Survival (OS)
|
25.91 Months
Interval 16.17 to
The high end of the range was not reached at time of analysis.
|
12 Months
Interval 6.58 to
The high end of the range was not reached at time of analysis.
|
Adverse Events
Panobinostat 5 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Panobinostat 10 mg
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panobinostat 5 mg
n=6 participants at risk
Participants who received 5 mg of Panobinostat along with 3 mg Ipililumab
|
Panobinostat 10 mg
n=11 participants at risk
Participants who received 10 mg of Panobinostat along with 3 mg Ipililumab
|
|---|---|---|
|
Investigations
Investigations - Other, Hypophysitis
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other, basal cell carcinoma
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Hydronephrosis
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Endocrine disorders
Endocrine disorders - Other, Hypophysitis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
27.3%
3/11 • Number of events 4 • 3 years, 9 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
General disorders
Fatigue
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
General disorders
Fever
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 3 • 3 years, 9 months
|
|
General disorders
Pain - Left groin/leg
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Infections and infestations
Infections and infestations - Other, Tested positive for adenovirus
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Infections and infestations
Lung infection - Pneumonia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
Other adverse events
| Measure |
Panobinostat 5 mg
n=6 participants at risk
Participants who received 5 mg of Panobinostat along with 3 mg Ipililumab
|
Panobinostat 10 mg
n=11 participants at risk
Participants who received 10 mg of Panobinostat along with 3 mg Ipililumab
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 6 • 3 years, 9 months
|
81.8%
9/11 • Number of events 33 • 3 years, 9 months
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 8 • 3 years, 9 months
|
72.7%
8/11 • Number of events 14 • 3 years, 9 months
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 6 • 3 years, 9 months
|
45.5%
5/11 • Number of events 12 • 3 years, 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
4/6 • Number of events 4 • 3 years, 9 months
|
27.3%
3/11 • Number of events 6 • 3 years, 9 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
36.4%
4/11 • Number of events 4 • 3 years, 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
27.3%
3/11 • Number of events 4 • 3 years, 9 months
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 11 • 3 years, 9 months
|
90.9%
10/11 • Number of events 20 • 3 years, 9 months
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
27.3%
3/11 • Number of events 4 • 3 years, 9 months
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 4 • 3 years, 9 months
|
|
General disorders
General disorders and administration site conditions - Other
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
General disorders
Chills
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
General disorders
Edema limbs
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
General disorders
Localized edema
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 4 • 3 years, 9 months
|
81.8%
9/11 • Number of events 10 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 4 • 3 years, 9 months
|
27.3%
3/11 • Number of events 9 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 8 • 3 years, 9 months
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Number of events 4 • 3 years, 9 months
|
18.2%
2/11 • Number of events 4 • 3 years, 9 months
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Investigations
Weight loss
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Investigations
Investigations - Other
|
33.3%
2/6 • Number of events 3 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 3 years, 9 months
|
36.4%
4/11 • Number of events 4 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 3 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
45.5%
5/11 • Number of events 6 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
2/6 • Number of events 2 • 3 years, 9 months
|
36.4%
4/11 • Number of events 5 • 3 years, 9 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
33.3%
2/6 • Number of events 3 • 3 years, 9 months
|
27.3%
3/11 • Number of events 6 • 3 years, 9 months
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
36.4%
4/11 • Number of events 5 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
27.3%
3/11 • Number of events 3 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 3 • 3 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 5 • 3 years, 9 months
|
18.2%
2/11 • Number of events 4 • 3 years, 9 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • 3 years, 9 months
|
9.1%
1/11 • Number of events 3 • 3 years, 9 months
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Nervous system disorders
Concentration impairment
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
18.2%
2/11 • Number of events 2 • 3 years, 9 months
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 3 • 3 years, 9 months
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 2 • 3 years, 9 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 3 years, 9 months
|
18.2%
2/11 • Number of events 4 • 3 years, 9 months
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • 3 years, 9 months
|
0.00%
0/11 • 3 years, 9 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
|
Immune system disorders
Immune system disorders - Other
|
0.00%
0/6 • 3 years, 9 months
|
9.1%
1/11 • Number of events 1 • 3 years, 9 months
|
Additional Information
Dr. Nikhil I. Khushalani
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place