FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT01896869
• Recruitment Status: Completed
• First Posted: July 11, 2013
• Results First Posted: May 6, 2020
• Last Update Posted: May 19, 2020
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: Ipilimumab; Biological: Vaccine; Drug: FOLFIRINOX
• Enrollment: 83

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Period Title: Overall Study
Started	41	42
Completed	40	36
Not Completed	1	6
Reason Not Completed
Withdrawal by Subject	0	6
Lost to Follow-up	1	0

Baseline Characteristics

Arm/Group Title		Ipilimumab + Vaccine	FOLFIRINOX	Total
Arm/Group Description		Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.	Total of all reporting groups
Overall Number of Baseline Participants		41	42	83
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	42 participants	83 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	30 73.2%	26 61.9%	56 67.5%
	>=65 years	11 26.8%	16 38.1%	27 32.5%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	42 participants	83 participants
	Female	17 41.5%	16 38.1%	33 39.8%
	Male	24 58.5%	26 61.9%	50 60.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	42 participants	83 participants
	Hispanic or Latino	0 0.0%	3 7.1%	3 3.6%
	Not Hispanic or Latino	41 100.0%	39 92.9%	80 96.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	42 participants	83 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	4 9.8%	3 7.1%	7 8.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 2.4%	3 7.1%	4 4.8%
	White	36 87.8%	36 85.7%	72 86.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
CA19-9 Secretors [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	42 participants	83 participants
		32 78.0%	31 73.8%	63 75.9%
		[1] Measure Description: Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL. Individuals with elevated CA19-9 were considered secretors. Those who did not express CA19-9 were considered non-secretors.
CA19-9 at baseline [1] [2]; Median (Inter-Quartile Range); Unit of measure: IU/mL
	Number Analyzed	32 participants	31 participants	63 participants
		185.0; (46.0 to 1091.5)	85.0; (41.6 to 178.7)	117.1; (44.7 to 372.6)
		[1] Measure Description: Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL.; [2] Measure Analysis Population Description: Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS)
Description	Overall Survival is the time between the date of randomization on study and death.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

1 Arm A (Ipilimumab + Vaccine) patient was lost to follow-up prior to treatment and was excluded from analysis.

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	40	42
Median (95% Confidence Interval); Unit of Measure: Months
	9.38; (5.0 to 12.2)	14.7; (11.6 to 20.0)

2. Secondary Outcome

Title	Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
Description	Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).
Time Frame	From the first dose of study drug through 70 days after last dose, up to 13 months

Outcome Measure Data

Analysis Population Description

AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity. Dose of Ipilimumab was reduced from 10 mg/kg to 3 mg/kg due to toxicity concerns. Toxicity rates are compared between these dosing subgroups.

Arm/Group Title	3 mg/kg	10 mg/kg
Arm/Group Description:	Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV Vaccine: 5x10^8 cells administered in 6 intradermal injections	Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 10 mg/kg administered IV Vaccine: 5x10^8 cells administered in 6 intradermal injections
Overall Number of Participants Analyzed	14	25
Measure Type: Count of Participants; Unit of Measure: Participants
Any study drug-related AE	13 92.9%	25 100.0%
adrenal insufficiency	0 0.0%	1 4.0%
alopecia	0 0.0%	1 4.0%
ALT increased	0 0.0%	2 8.0%
arthralgia	0 0.0%	2 8.0%
AST increased	0 0.0%	1 4.0%
chills	2 14.3%	5 20.0%
colitis	1 7.1%	4 16.0%
cough	0 0.0%	1 4.0%
diarrhea	1 7.1%	2 8.0%
dry mouth	0 0.0%	1 4.0%
dry skin	1 7.1%	0 0.0%
edema face	0 0.0%	1 4.0%
fatigue	1 7.1%	7 28.0%
fever	3 21.4%	11 44.0%
flu-like symptoms	1 7.1%	2 8.0%
flushing	0 0.0%	1 4.0%
hepatitis	0 0.0%	1 4.0%
hyperhidrosis	0 0.0%	2 8.0%
hypophysitis	1 7.1%	2 8.0%
hypotension	0 0.0%	1 4.0%
hypothyroidism	0 0.0%	1 4.0%
lymph node pain	0 0.0%	2 8.0%
lymph node swelling	0 0.0%	1 4.0%
malaise	1 7.1%	0 0.0%
myalgia	2 14.3%	0 0.0%
nausea	1 7.1%	2 8.0%
pneumonitis	0 0.0%	1 4.0%
pruritus	2 14.3%	7 28.0%
rash	8 57.1%	18 72.0%
swelling, chest wall mass	0 0.0%	1 4.0%
thyroiditis	0 0.0%	1 4.0%
urticaria	2 14.3%	1 4.0%
vomiting	1 7.1%	2 8.0%
weight loss	0 0.0%	1 4.0%
vaccine site blisters	1 7.1%	4 16.0%
vaccine site bruising	1 7.1%	2 8.0%
vaccine site erythema	11 78.6%	20 80.0%
vaccine site flares	0 0.0%	2 8.0%
vaccine site induration	12 85.7%	25 100.0%
vaccine site oozing	0 0.0%	1 4.0%
vaccine site pruritus	11 78.6%	22 88.0%
vaccine site scabbing	0 0.0%	1 4.0%
vaccine site tenderness	3 21.4%	13 52.0%

3. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	40	42
Median (95% Confidence Interval); Unit of Measure: Months
	2.40; (1.87 to 2.53)	5.55; (3.32 to 8.51)

4. Secondary Outcome

Title	Immune-related Progression Free Survival (irPFS)
Description	Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	40	42
Median (95% Confidence Interval); Unit of Measure: Months
	2.50; (2.14 to 2.92)	5.55; (3.38 to 8.51)

5. Secondary Outcome

Title	Objective Response Rate
Description	Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame	Assessed until disease progression, up to 2 years

Outcome Measure Data

Analysis Population Description

6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	35	29
Measure Type: Count of Participants; Unit of Measure: Participants
	1 2.9%	3 10.3%

6. Secondary Outcome

Title	Immune-related Objective Response Rate
Description	Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
Time Frame	Assessed until disease progression, up to 2 years

Outcome Measure Data

Analysis Population Description

6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	35	29
Measure Type: Count of Participants; Unit of Measure: Participants
	2 5.7%	4 13.8%

7. Secondary Outcome

Title	Duration of Response
Description	Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
Time Frame	Up to 22 months

Outcome Measure Data

Analysis Population Description

Only 1 patient on Arm A (Ipilimumab + Vaccine) and 3 patients on Arm B (FOLFIRINOX) achieved a response by RECIST and were included in this analysis. 2 additional patients (1 Arm A and 1 Arm B) achieved a response by irRC, but these patients were both taken off study the same day as their partial response, for disease progression by RECIST.

Arm/Group Title	Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:	Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed	1	3
Mean (Full Range); Unit of Measure: months
	2.5; (2.5 to 2.5)	8.49; (2.73 to 17.45)

8. Secondary Outcome

Title	Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Description	Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.
Time Frame	Baseline, Week 7, and Week 10 visits

Outcome Measure Data

Analysis Population Description

Only patients who were considered CA19-9 secretors (expressed CA19-9 either on study or prior to study) were included in the analysis. 32 in Arm A (Ipilimumab+Vaccine) and 31 in Arm B (FOLFIRINOX). Only subjects evaluable for this outcome at the specified time points had CA19-9 drawn and could be included in the analysis.

Arm/Group Title		Ipilimumab + Vaccine	FOLFIRINOX
Arm/Group Description:		Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections	Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Overall Number of Participants Analyzed		32	31
Median (Inter-Quartile Range); Unit of Measure: IU/mL
Baseline	Number Analyzed	32 participants	31 participants
		185.0; (46.0 to 1091.5)	85.0; (41.6 to 178.7)
Week 7	Number Analyzed	26 participants	21 participants
		189.2; (61.2 to 7123.7)	77.9; (23.4 to 430.0)
Week 10	Number Analyzed	18 participants	15 participants
		237.1; (64.4 to 4690.1)	66.8; (24.0 to 443.5)

Adverse Events

Time Frame	Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
Adverse Event Reporting Description	AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
Arm/Group Title	Ipilimumab + Vaccine
Arm/Group Description	Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections
All-Cause Mortality
	Ipilimumab + Vaccine
	Affected / at Risk (%)
Total	5/39 (12.82%)
Serious Adverse Events
	Ipilimumab + Vaccine
	Affected / at Risk (%)
Total	20/39 (51.28%)
Endocrine disorders
adrenal insufficiency *	1/39 (2.56%)
hypophysitis *	1/39 (2.56%)
Gastrointestinal disorders
abdominal pain *	2/39 (5.13%)
colitis *	3/39 (7.69%)
diarrhea *	2/39 (5.13%)
malabsorption *	1/39 (2.56%)
nausea *	1/39 (2.56%)
obstruction gastric *	1/39 (2.56%)
vomiting *	2/39 (5.13%)
Infections and infestations
bacteremia *	1/39 (2.56%)
catheter related infection *	1/39 (2.56%)
lung infection *	2/39 (5.13%)
sepsis *	2/39 (5.13%)
Investigations
alkaline phosphatase increased *	1/39 (2.56%)
blood bilirubin increased *	2/39 (5.13%)
INR increased *	1/39 (2.56%)
neutropenia *	1/39 (2.56%)
platelet count decreased *	1/39 (2.56%)
weight loss *	1/39 (2.56%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death, disease progression *	5/39 (12.82%)
Psychiatric disorders
delerium *	1/39 (2.56%)
Renal and urinary disorders
acute kidney injury *	1/39 (2.56%)
Respiratory, thoracic and mediastinal disorders
chest wall pain *	1/39 (2.56%)
dyspnea *	1/39 (2.56%)
pneumonitis *	1/39 (2.56%)
Vascular disorders
thromboembolic event - pulmonary embolism *	1/39 (2.56%)
* Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ipilimumab + Vaccine
	Affected / at Risk (%)
Total	39/39 (100.00%)
Blood and lymphatic system disorders
lymph node pain *	2/39 (5.13%)
Cardiac disorders
sinus tachycardia *	4/39 (10.26%)
Endocrine disorders
hypophysitis *	3/39 (7.69%)
Gastrointestinal disorders
abdominal distention *	3/39 (7.69%)
abdominal pain *	13/39 (33.33%)
ascites *	5/39 (12.82%)
bloating *	5/39 (12.82%)
colitis *	4/39 (10.26%)
constipation *	14/39 (35.90%)
diarrhea *	12/39 (30.77%)
dry mouth *	3/39 (7.69%)
dyspepsia *	3/39 (7.69%)
flatulence *	2/39 (5.13%)
nausea *	12/39 (30.77%)
oral pain *	2/39 (5.13%)
vomiting *	11/39 (28.21%)
General disorders
chills *	12/39 (30.77%)
cold intolerance *	2/39 (5.13%)
edema limbs *	5/39 (12.82%)
fatigue *	17/39 (43.59%)
fever *	20/39 (51.28%)
flu-like symptoms *	3/39 (7.69%)
gait disturbance *	2/39 (5.13%)
non-cardiac pain *	5/39 (12.82%)
vaccine site blisters *	5/39 (12.82%)
vaccine site bruising *	3/39 (7.69%)
vaccine site erythema *	31/39 (79.49%)
vaccine site flares *	2/39 (5.13%)
vaccine site induration *	37/39 (94.87%)
vaccine site pruritus *	33/39 (84.62%)
vaccine site tenderness *	16/39 (41.03%)
Infections and infestations
upper respiratory infection *	3/39 (7.69%)
urinary tract infection *	2/39 (5.13%)
Injury, poisoning and procedural complications
bruising *	4/39 (10.26%)
fall *	2/39 (5.13%)
pain, site of procedure/conmed *	3/39 (7.69%)
Investigations
alkaline phosphatase increased *	3/39 (7.69%)
alanine aminotransferase (ALT) increased *	5/39 (12.82%)
anemia *	4/39 (10.26%)
aspartate aminotransferase (AST) increased *	3/39 (7.69%)
blood bilirubin increased *	2/39 (5.13%)
lymphocyte count decreased *	2/39 (5.13%)
platelet count decreased *	4/39 (10.26%)
weight loss *	5/39 (12.82%)
Metabolism and nutrition disorders
anorexia *	9/39 (23.08%)
hyperglycemia *	2/39 (5.13%)
hypokalemia *	2/39 (5.13%)
hypophosphatemia *	2/39 (5.13%)
Musculoskeletal and connective tissue disorders
arthralgia *	6/39 (15.38%)
back pain *	7/39 (17.95%)
muscle cramp *	3/39 (7.69%)
myalgia *	2/39 (5.13%)
Nervous system disorders
dizziness *	4/39 (10.26%)
headache *	6/39 (15.38%)
peripheral sensory neuropathy *	2/39 (5.13%)
Psychiatric disorders
anxiety *	7/39 (17.95%)
depression *	3/39 (7.69%)
insomnia *	12/39 (30.77%)
Renal and urinary disorders
difficulty urinating *	2/39 (5.13%)
urinary frequency *	2/39 (5.13%)
Reproductive system and breast disorders
rhinitis *	2/39 (5.13%)
Respiratory, thoracic and mediastinal disorders
atelectasis *	4/39 (10.26%)
cough *	6/39 (15.38%)
dyspnea *	5/39 (12.82%)
pleural effusion *	3/39 (7.69%)
Skin and subcutaneous tissue disorders
dry skin *	2/39 (5.13%)
hyperhidrosis *	5/39 (12.82%)
pruritus *	9/39 (23.08%)
rash *	28/39 (71.79%)
urticaria *	3/39 (7.69%)
Vascular disorders
hot flashes *	2/39 (5.13%)
hypotension *	5/39 (12.82%)
thromboembolic event *	3/39 (7.69%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.

Results Point of Contact

• Name/Title: Dr. Dung Le
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Phone: 443-287-0002
• EMail: dle2@jhmi.edu

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT01896869
• Other Study ID Numbers: J13108; NA_00086350 ( Other Identifier: JHMIRB ); FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Results First Submitted: April 22, 2020
• Results First Posted: May 6, 2020
• Last Update Posted: May 19, 2020