Trial Outcomes & Findings for Sequential Vaccinations in Prostate Cancer Patients (NCT NCT00060528)
NCT ID: NCT00060528
Last Updated: 2017-10-26
Results Overview
Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
48 months
Results posted on
2017-10-26
Participant Flow
32 patients were accrued to the phase II portion of the study
Participant milestones
| Measure |
rF-GM (10^7pfu)
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
no GM
Vaccine subcutaneously with no GM
|
Rec-hGM
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sequential Vaccinations in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Prostate Cancer Patients
n=32 Participants
Progressive Metastatic Castration Resistant Prostate Cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 monthsImmune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.
Outcome measures
| Measure |
No GM
n=8 Participants
Vaccine subcutaneously with no GM
|
Rec-hGM
n=6 Participants
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu),
n=7 Participants
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
n=8 Participants
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Number of Participants With an Immune Response
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 53 monthsPopulation: PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response
PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)
Outcome measures
| Measure |
No GM
n=32 Participants
Vaccine subcutaneously with no GM
|
Rec-hGM
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu),
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels
|
15.6 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 53 monthsPopulation: All 12 participants with measurable disease were evaluated.
Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...
Outcome measures
| Measure |
No GM
n=12 Participants
Vaccine subcutaneously with no GM
|
Rec-hGM
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu),
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Number of Participants With an Objective Response
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 50 monthsOverall survival is defined as the date of on-study to the date of death from any cause or last follow-up.
Outcome measures
| Measure |
No GM
n=32 Participants
Vaccine subcutaneously with no GM
|
Rec-hGM
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu),
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Overall Survival
|
26.6 Months
Interval 6.0 to 50.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 77.5 monthsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
No GM
n=32 Participants
Vaccine subcutaneously with no GM
|
Rec-hGM
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu),
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
The Number of Participants With Adverse Events
|
32 Participants
|
—
|
—
|
—
|
Adverse Events
no GM
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Rec-hGM
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
rF-GM (10^7pfu)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
rF-GM (10^8)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
no GM
n=8 participants at risk
Vaccine subcutaneously with no GM
|
Rec-hGM
n=9 participants at risk
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu)
n=7 participants at risk
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
n=8 participants at risk
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular arrhythmias (supraventricular tachycardia (SVT)/atrial fibrillation/flutter)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
General disorders
Constitutional Symptoms-Other (Specify_)
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Nervous system disorders
Mood alteration-depression
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • 77.5 months
|
22.2%
2/9 • Number of events 2 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
Other adverse events
| Measure |
no GM
n=8 participants at risk
Vaccine subcutaneously with no GM
|
Rec-hGM
n=9 participants at risk
Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
|
rF-GM (10^7pfu)
n=7 participants at risk
Vaccine subcutaneously with rF-GM (10\^7pfu) subcutaneously x1
|
rF-GM (10^8)
n=8 participants at risk
Vaccine subcutaneously with rF-GM (10\^8) subcutaneously x1
|
|---|---|---|---|---|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
50.0%
4/8 • Number of events 5 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
42.9%
3/7 • Number of events 5 • 77.5 months
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
|
Renal and urinary disorders
Creatinine
|
37.5%
3/8 • Number of events 7 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • 77.5 months
|
22.2%
2/9 • Number of events 5 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
50.0%
4/8 • Number of events 6 • 77.5 months
|
44.4%
4/9 • Number of events 9 • 77.5 months
|
28.6%
2/7 • Number of events 5 • 77.5 months
|
37.5%
3/8 • Number of events 3 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
87.5%
7/8 • Number of events 30 • 77.5 months
|
88.9%
8/9 • Number of events 20 • 77.5 months
|
85.7%
6/7 • Number of events 40 • 77.5 months
|
87.5%
7/8 • Number of events 21 • 77.5 months
|
|
Social circumstances
Rash/desquamation
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
12.5%
1/8 • Number of events 4 • 77.5 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
50.0%
4/8 • Number of events 5 • 77.5 months
|
44.4%
4/9 • Number of events 6 • 77.5 months
|
71.4%
5/7 • Number of events 17 • 77.5 months
|
87.5%
7/8 • Number of events 9 • 77.5 months
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase) (alanine aminotransferase)
|
37.5%
3/8 • Number of events 3 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
42.9%
3/7 • Number of events 5 • 77.5 months
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8 • Number of events 14 • 77.5 months
|
77.8%
7/9 • Number of events 11 • 77.5 months
|
85.7%
6/7 • Number of events 13 • 77.5 months
|
37.5%
3/8 • Number of events 6 • 77.5 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
11.1%
1/9 • Number of events 2 • 77.5 months
|
14.3%
1/7 • Number of events 3 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 6 • 77.5 months
|
33.3%
3/9 • Number of events 5 • 77.5 months
|
42.9%
3/7 • Number of events 3 • 77.5 months
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase) (aspartate aminotransferase)
|
62.5%
5/8 • Number of events 5 • 77.5 months
|
33.3%
3/9 • Number of events 4 • 77.5 months
|
71.4%
5/7 • Number of events 9 • 77.5 months
|
50.0%
4/8 • Number of events 5 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
22.2%
2/9 • Number of events 3 • 77.5 months
|
57.1%
4/7 • Number of events 5 • 77.5 months
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
50.0%
4/8 • Number of events 10 • 77.5 months
|
44.4%
4/9 • Number of events 5 • 77.5 months
|
71.4%
5/7 • Number of events 12 • 77.5 months
|
37.5%
3/8 • Number of events 5 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 2 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Reproductive system and breast disorders
Abdominal pain or cramping
|
0.00%
0/8 • 77.5 months
|
22.2%
2/9 • Number of events 3 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 4 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
28.6%
2/7 • Number of events 3 • 77.5 months
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood cell (WBC))
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Blood and lymphatic system disorders
Platelets
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Cardiac disorders
Vasovagal episode
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Cardiac disorders
Edema
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Cardiac disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Congenital, familial and genetic disorders
Prothrombin time (PT)
|
12.5%
1/8 • Number of events 3 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
General disorders
Rigors, chills
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
22.2%
2/9 • Number of events 5 • 77.5 months
|
28.6%
2/7 • Number of events 4 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
General disorders
Sweating (diaphoresis)
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
|
General disorders
Weight loss
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
22.2%
2/9 • Number of events 2 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
12.5%
1/8 • Number of events 3 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Wound-non-infectious
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odonphagia (painful swallowing)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
|
Gastrointestinal disorders
Mouth dryness
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Blood and lymphatic system disorders
Hematuria (in the absence of vaginal bleeding)
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
37.5%
3/8 • Number of events 3 • 77.5 months
|
33.3%
3/9 • Number of events 5 • 77.5 months
|
57.1%
4/7 • Number of events 5 • 77.5 months
|
37.5%
3/8 • Number of events 4 • 77.5 months
|
|
Hepatobiliary disorders
Bilirubin
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Bicarbonate
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Hypermagnesemia
|
12.5%
1/8 • Number of events 4 • 77.5 months
|
33.3%
3/9 • Number of events 3 • 77.5 months
|
28.6%
2/7 • Number of events 3 • 77.5 months
|
25.0%
2/8 • Number of events 3 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
22.2%
2/9 • Number of events 4 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
25.0%
2/8 • Number of events 2 • 77.5 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
25.0%
2/8 • Number of events 4 • 77.5 months
|
22.2%
2/9 • Number of events 4 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
25.0%
2/8 • Number of events 6 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 2 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Psychiatric disorders
Syncope (fainting)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
General disorders
Sense of smell
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Nervous system disorders
Mood alteration/depression
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Infections and infestations
Chest pain (non-cardiac and non-pleuritic)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Ear and labyrinth disorders
Earache (otalgia)
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Reproductive system and breast disorders
Headache
|
0.00%
0/8 • 77.5 months
|
33.3%
3/9 • Number of events 4 • 77.5 months
|
14.3%
1/7 • Number of events 3 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
General disorders
Pain-Other (Specify_)
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
28.6%
2/7 • Number of events 4 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Cardiac disorders
Thrombosis/embolism
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Nervous system disorders
Insomnia
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 2 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Nervous system disorders
Mood alteration-anxiety, agitation
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
General disorders
Syndromes-Other (Specify-flu like syndrome)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify_)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Ear and labyrinth disorders
Epistaxis
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
4/8 • Number of events 7 • 77.5 months
|
44.4%
4/9 • Number of events 5 • 77.5 months
|
57.1%
4/7 • Number of events 5 • 77.5 months
|
87.5%
7/8 • Number of events 12 • 77.5 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC <1.0x10e9/L)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
33.3%
3/9 • Number of events 3 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
25.0%
2/8 • Number of events 5 • 77.5 months
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Hepatobiliary disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 3 • 77.5 months
|
|
Cardiac disorders
Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Cardiac disorders
Hypertension
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Nervous system disorders
Confusion
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/8 • 77.5 months
|
11.1%
1/9 • Number of events 1 • 77.5 months
|
14.3%
1/7 • Number of events 2 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Gastrointestinal disorders
Diarrhea patients with a colostomy
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
14.3%
1/7 • Number of events 1 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
28.6%
2/7 • Number of events 2 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
0.00%
0/8 • 77.5 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/8 • 77.5 months
|
0.00%
0/9 • 77.5 months
|
0.00%
0/7 • 77.5 months
|
12.5%
1/8 • Number of events 1 • 77.5 months
|
Additional Information
James L. Gulley, M.D.
National Cancer Instititute (NCI), National Institutes of Health (NIH)
Phone: 301-435-2956
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place