Trial Outcomes & Findings for Ipilimumab + Androgen Depravation Therapy in Prostate Cancer (NCT NCT01377389)
NCT ID: NCT01377389
Last Updated: 2023-09-29
Results Overview
Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
at the end of 7 months on treatment
Results posted on
2023-09-29
Participant Flow
All patients enrolled at MD Anderson Cancer Center between 2011-2013
All patients were screened according to inclusion and exclusion criteria as outlined per protocol.
Participant milestones
| Measure |
Ipilimumab and Androgen Depravation
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ipilimumab and Androgen Depravation
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen failure
|
2
|
Baseline Characteristics
Ipilimumab + Androgen Depravation Therapy in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Ipilimumab and Androgen Depravation
n=30 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 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
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the end of 7 months on treatmentPopulation: Out of 27 participants, 24 were evaluable for outcome analysis.
Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=24 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Number of Participants Who Progressed After 7 Months of Being on Treatment
PSA progression at 7 months
|
6 Participants
|
|
Number of Participants Who Progressed After 7 Months of Being on Treatment
No PSA progression at 7 months
|
18 Participants
|
SECONDARY outcome
Timeframe: Each evaluable patient was followed from the time of their first dose until 30 days after their last dose of study drugPopulation: 9 were evaluable for outcome analysis out of 11 participants
CD8 T-cells are known as cytotoxic T-cells or "killer" T-cells. When the resting CD8 T-cells are activated, the activated CD8 T-cells multiple to fight a specific target so creating a group of specifically activated T-cells. This test measured the minimal number of clonal expansions of CD8 T-cells that always preceded an adverse response to treatment that was due to increased activity in the immune system itself. The minimal number of clonal expansion points to what this increased activity in the immune system might look like.
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=9 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
The Number of Clonal Expansion of Cluster of Differentiation 8 (CD8) T-cells
|
55 clonal expansions
|
SECONDARY outcome
Timeframe: 1 month up to 7 months.Population: Out of 27 participants, 24 were evaluable for outcome analysis.
The presence of testosterone was followed in each patient from the start of treatment until the testosterone lab test was found to be at a value greater than 50ng/mL.
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=24 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Time to Testosterone Recovery (> 50ng/mL) in Patients Treated With Intermittent ADT Plus Ipilimumab.
|
3.4 months
Interval 1.3 to 6.6
|
SECONDARY outcome
Timeframe: 2 to 45 monthsThe number of months after the last ADT dose until the PSA progression
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=18 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Time to Progression of Disease (PD) Off Androgen Depravation Therapy (ADT), After Treatment With Intermittent ADT Plus Ipilimumab.
|
8.0 months
Interval 2.0 to 45.3
|
SECONDARY outcome
Timeframe: From the first dose to the last follow-up, up to 60 monthsThe total number of adverse events which were related to one of the study drugs. Grade 1- Mild, asymptomatic of mild symptoms; clinical or diagnostic observation only; intervention not indicated. Grade 2- Moderate, minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental (daily living activities). Grate 3- Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care of daily life activities.
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=27 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
The Total Number of Study Drug Related Events Indicated by the Participants
Grade 1
|
113 related events
|
|
The Total Number of Study Drug Related Events Indicated by the Participants
Grade 2
|
55 related events
|
|
The Total Number of Study Drug Related Events Indicated by the Participants
Grade 3
|
25 related events
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of first documented progression or date of death from any case, whichever came first, assessed up to 70 months.Population: Only 22 was analyzed, 5 were uncensored.
Overall survival of patients treated with intermittent ADT and ipilimumab in months.
Outcome measures
| Measure |
Ipilimumab and Androgen Depravation
n=22 Participants
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Overall Survival
|
36 months
Interval 14.2 to 53.0
|
Adverse Events
Ipilimumab and Androgen Depravation
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab and Androgen Depravation
n=27 participants at risk
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Hepatobiliary disorders
ALT
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
AST
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Renal Insufficiency
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Hematuria
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Edema
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
CNS Cerebrovascular ischemia (CVA)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Adrenal Insufficiency
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Hemorrage, GI-rectum
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Pain-abdomen NOS
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystitis
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Psychiatric disorders
Neurgology-other: Delirium (altered mental status)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Other: Panhypopituitarism
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
Other adverse events
| Measure |
Ipilimumab and Androgen Depravation
n=27 participants at risk
Participants with castrate sensitive prostate carcinoma
|
|---|---|
|
Renal and urinary disorders
Creatinine
|
18.5%
5/27 • Number of events 9 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystitis
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
22.2%
6/27 • Number of events 10 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
51.9%
14/27 • Number of events 28 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
7.4%
2/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Dysgeusia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
22.2%
6/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Edema: head and neck
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Abdominal Pain
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Adrenal Insufficiency
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Alanine Aminotransferase increased
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Albumin, serum-low (hypoalbuminemia)
|
22.2%
6/27 • Number of events 8 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
48.1%
13/27 • Number of events 19 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
General disorders
Allergy/Immunology-Other (Specify)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
59.3%
16/27 • Number of events 38 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Amylase
|
29.6%
8/27 • Number of events 12 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
3/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-specific)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
59.3%
16/27 • Number of events 37 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Ear and labyrinth disorders
Auditory/Ear-Other (Specify)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Back pain
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
33.3%
9/27 • Number of events 12 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
18.5%
5/27 • Number of events 16 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify)
|
37.0%
10/27 • Number of events 17 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Eye disorders
Blurred vision
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Bone pain
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholestremia)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Psychiatric disorders
Confusion
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Constitutional Symptoms-Other (Specify)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
7/27 • Number of events 8 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Edema: limb
|
11.1%
3/27 • Number of events 17 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Endocrine-Other (Specify)
|
14.8%
4/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Fatigue (asthenia, lethargy, malaise)
|
81.5%
22/27 • Number of events 44 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Febrile neutropenia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 per liter)
|
14.8%
4/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Flank pain
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Flatulence
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Flu-like syndrome
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specity)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Hepatobiliary disorders
GGT (gamma-Glutamyl transpeptidase)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
77.8%
21/27 • Number of events 56 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Hair loss/alopecia (scalp or body)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
92.6%
25/27 • Number of events 56 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Hemoglobinuria
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Hemorrhage, GI--Select
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Hemorrhage, GU--Select (Kidney)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Hot flashes
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Hot flashes/flushes
|
55.6%
15/27 • Number of events 18 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Cardiac disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Cardiac disorders
Hypertension (Adult)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Cardiac disorders
Hypotension
|
7.4%
2/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Incontinence, urinary
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils--Select (Sinus)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Infection with unknown ANC--Select
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Infections and infestations
Infection-Other (Specify)
|
14.8%
4/27 • Number of events 5 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Insomnia
|
22.2%
6/27 • Number of events 11 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Investigations - Other, specify
|
3.7%
1/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
7.4%
2/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Leukocytes (Total WBC)
|
22.2%
6/27 • Number of events 12 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Lipase
|
33.3%
9/27 • Number of events 18 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Localized edema
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Lymphopenia
|
22.2%
6/27 • Number of events 9 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
33.3%
9/27 • Number of events 13 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-Other (Specify)
|
7.4%
2/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Psychiatric disorders
Mood alteration--Select
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Psychiatric disorders
Mood alteration--Select (Anxiety)
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral Cavity)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
14.8%
4/27 • Number of events 5 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity - lower)
|
7.4%
2/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Whole body/generalized)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other (Specify)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
9/27 • Number of events 17 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Neurology-Other (Specify)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy: sensory
|
22.2%
6/27 • Number of events 7 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Neutrophil count decreased
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Neutrophils/granulocytes (ANC/AGC)
|
3.7%
1/27 • Number of events 5 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain
|
11.1%
3/27 • Number of events 12 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain-Other (Specify)
|
51.9%
14/27 • Number of events 34 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Abdomen NOS)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Back)
|
18.5%
5/27 • Number of events 5 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Extremity-limb)
|
3.7%
1/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Head/headache)
|
14.8%
4/27 • Number of events 8 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Joint)
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Kidney)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Pain NOS)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Pelvis)
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Prostate)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Pain--Select (Rectum)
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Platelets
|
18.5%
5/27 • Number of events 11 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Pneumonitis/pulmonary infiltrates
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
7.4%
2/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.1%
3/27 • Number of events 5 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Proteinuria
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
66.7%
18/27 • Number of events 40 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.7%
1/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Nervous system disorders
Rigors/chills
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
29.6%
8/27 • Number of events 11 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia--Select (Sinus bradycardia)
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
14.8%
4/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
37.0%
10/27 • Number of events 12 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
59.3%
16/27 • Number of events 18 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Eye disorders
Vision-blurred vision
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 9 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
11.1%
3/27 • Number of events 3 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Weight gain
|
3.7%
1/27 • Number of events 1 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Metabolism and nutrition disorders
Weight loss
|
11.1%
3/27 • Number of events 4 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
7.4%
2/27 • Number of events 2 • Adverse events collected prior to each dose every 4 weeks for 6 months after the last dose is administered.
Adverse events are documented according to protocol requirements.
|
Additional Information
Aparicio,Ana,M.D. / Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place