Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

• Sponsor: Patrick Joseph Loehrer Sr. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00198133
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 88
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To study the efficacy of Alimta as a single agent in thymic cancers

Condition or Disease	Intervention/Treatment	Phase
Thymoma; Thymic Carcinoma	Drug: Premetrexed (Alimta)	Phase 2

Detailed Description

The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemetrexed Pemetrexed infusion once every 21 days (one cycle).	Drug: Premetrexed (Alimta); Pemetrexed will be 500 mg/m2 IV every 3 weeks

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (Complete and Partial Response) [Up to 3 years]

   The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.

Secondary Outcome Measures

1. Duration of Remission [Time from the date of remission until progression or death, assessed up to 3 years]

   Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.

2. Grade 3/4 Treatment Related Adverse Events [Up to 3 years]

   To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.

• Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.

• Patients may have had prior chemotherapy for metastatic disease

• Adequate organ function as defined by: bili </=1.5; calc. crt clr of >/=45; hematologic-granulocytes >/=1500 & plt >/=100K.

• Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.

• ECOG performance status of 0 or 1

Exclusion Criteria:

• Acute intercurrent infection or complications

• pregnancy or lactating patients

• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.

• Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Patrick Joseph Loehrer Sr.

Investigators

• Principal Investigator: Patrick Loehrer, M.D., Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16.

• Responsible Party: Patrick Joseph Loehrer Sr., Professor of Medicine, Indiana University School of Medicine
• ClinicalTrials.gov Identifier: NCT00198133
• Other Study ID Numbers: 0412-18; IUCRO-0088; IUCRO-0088
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 22, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Patrick Joseph Loehrer Sr., Professor of Medicine, Indiana University School of Medicine: Thymoma; Thymic Carcinoma
• Additional relevant MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms; Pemetrexed

Study Results

Participant Flow

Recruitment Details	This protocol was based on getting 27 evaluable patients through a two-stage design

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
Period Title: Overall Study
STARTED	16	11
COMPLETED	11	3
NOT COMPLETED	5	8

Baseline Characteristics

Arm/Group Title	Thymoma	Thymic Carcinoma	Total
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Total of all reporting groups
Overall Participants	16	11	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.2 (14.2)	53.3 (14.4)	53.8 (14.0)
Sex: Female, Male (Count of Participants)
Female	9 56.3%	4 36.4%	13 48.1%
Male	7 43.8%	7 63.6%	14 51.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 100%	11 100%	27 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 6.3%	1 9.1%	2 7.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 12.5%	0 0%	2 7.4%
White	13 81.3%	10 90.9%	23 85.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (Complete and Partial Response)
Description	The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All patients with at least one post baseline measurement. (26 evaluable - 15 T and 11 TC patients)

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
Measure Participants	15	11
Number (95% Confidence Interval) [percentage of participants]	26.7 166.9%	9.1 82.7%

2. Secondary Outcome

Title	Duration of Remission
Description	Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
Time Frame	Time from the date of remission until progression or death, assessed up to 3 years

Outcome Measure Data

Analysis Population Description

All patients with at least one post baseline measurement who had a response of CR or PR

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
Measure Participants	4	1
Median (95% Confidence Interval) [months]	4.0	3.8

3. Secondary Outcome

Title	Grade 3/4 Treatment Related Adverse Events
Description	To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks	Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
Measure Participants	16	11
Number [participants]	1 6.3%	1 9.1%

Adverse Events

Time Frame	Beginning of treatment until the end of the study, up to 3 years
Arm/Group Title	Thymoma		Thymic Carcinoma
Arm/Group Description	Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks		Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
All Cause Mortality
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		3/11 (27.3%)
Cardiac disorders
SUPERIOR VENA CAVA SYNDROME (SVC)	0/16 (0%)		1/11 (9.1%)
Gastrointestinal disorders
ABDOMINAL PAIN	0/16 (0%)		1/11 (9.1%)
DYSPNEA	1/16 (6.3%)		0/11 (0%)
General disorders
FATIGUE	1/16 (6.3%)		0/11 (0%)
FEVER	0/16 (0%)		1/11 (9.1%)
Infections and infestations
BLOOD INFECTION (STAPHLOCOCCUS HOMINIS)	0/16 (0%)		1/11 (9.1%)
URINARY TRACT INFECTION	1/16 (6.3%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
ACHALASIA	1/16 (6.3%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
PNEUMONIA	1/16 (6.3%)		0/11 (0%)
PNEUMONITIS	0/16 (0%)		1/11 (9.1%)
Other (Not Including Serious) Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/16 (100%)		11/11 (100%)
Blood and lymphatic system disorders
ANC (NEUTROPENIA)	1/16 (6.3%)		0/11 (0%)
ANEMIA	0/16 (0%)		1/11 (9.1%)
ANKLE EDEMA	0/16 (0%)		2/11 (18.2%)
BILATERAL ANKLE EDEMA	1/16 (6.3%)		0/11 (0%)
EDEMA +1	0/16 (0%)		1/11 (9.1%)
EDEMA - ANKLES	1/16 (6.3%)		0/11 (0%)
EDEMA-LEFT ARM	1/16 (6.3%)		0/11 (0%)
SWOLLEN FACE/RED	1/16 (6.3%)		0/11 (0%)
Cardiac disorders
ARRHYTHIA (TACHYCARDIA)	1/16 (6.3%)		0/11 (0%)
ATRIAL FIBRILLATION	1/16 (6.3%)		0/11 (0%)
PERICARDIAL TAMPONADE	0/16 (0%)		1/11 (9.1%)
Ear and labyrinth disorders
VERTIGO	1/16 (6.3%)		0/11 (0%)
Endocrine disorders
DIABETES	0/16 (0%)		1/11 (9.1%)
HYPOTHYROID	1/16 (6.3%)		0/11 (0%)
HYPOTHYROIDISM	1/16 (6.3%)		1/11 (9.1%)
Eye disorders
BLURRY VISION	1/16 (6.3%)		0/11 (0%)
DRY EYES	0/16 (0%)		2/11 (18.2%)
EYE DRAINAGE/ REDNESS	1/16 (6.3%)		0/11 (0%)
EYE SWELLING	0/16 (0%)		1/11 (9.1%)
Gastrointestinal disorders
ABDOMINAL PAIN	0/16 (0%)		1/11 (9.1%)
ANOREXIA (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
BLOATING	0/16 (0%)		1/11 (9.1%)
CANDIDA ESOPHAGITIS	1/16 (6.3%)		0/11 (0%)
CONSTIPATION	4/16 (25%)		6/11 (54.5%)
DIARRHEA	5/16 (31.3%)		1/11 (9.1%)
DIARRHEA (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
DYSPEPSIA	4/16 (25%)		2/11 (18.2%)
DYSPEPSIA (HEARTBURN)/REFLUX	0/16 (0%)		1/11 (9.1%)
DYSPEPSIA (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
DYSPEPSIA (STOMACH ACHE)	1/16 (6.3%)		0/11 (0%)
DYSPNEA	9/16 (56.3%)		8/11 (72.7%)
DYSPNEA (INTERMITTENT)	1/16 (6.3%)		1/11 (9.1%)
GAS	1/16 (6.3%)		0/11 (0%)
GERD	1/16 (6.3%)		1/11 (9.1%)
HEARTBURN	0/16 (0%)		1/11 (9.1%)
INCONTINENCE	2/16 (12.5%)		0/11 (0%)
INTEMITTENT DYSPEPSIA	0/16 (0%)		1/11 (9.1%)
INTERMITTENT CONSTIPATION	1/16 (6.3%)		0/11 (0%)
INTERMITTENT DIARRHEA	1/16 (6.3%)		0/11 (0%)
INTERMITTENT DYSPEPSIA	2/16 (12.5%)		0/11 (0%)
INTERMITTENT NAUSEA	3/16 (18.8%)		2/11 (18.2%)
INTERMITTENT STOMACH PAIN	1/16 (6.3%)		0/11 (0%)
INTERMITTENT VOMITTING	1/16 (6.3%)		1/11 (9.1%)
MUCOSITIS	5/16 (31.3%)		0/11 (0%)
MUCOSITIS (THRUSH)	1/16 (6.3%)		0/11 (0%)
MUCOSITIS - ORAL CAVITY (MOUTH ULCERS)	1/16 (6.3%)		0/11 (0%)
MUCOSITIS/STOMATITIS	1/16 (6.3%)		0/11 (0%)
NAUSEA	4/16 (25%)		6/11 (54.5%)
NAUSEA (INTERMITTENT)	2/16 (12.5%)		0/11 (0%)
NAUSEA INTERMITTENT	1/16 (6.3%)		0/11 (0%)
STOMATITIS	1/16 (6.3%)		0/11 (0%)
TASTE ALTERATION	4/16 (25%)		2/11 (18.2%)
VOMITING	2/16 (12.5%)		4/11 (36.4%)
General disorders
FATIGUE	12/16 (75%)		10/11 (90.9%)
FEVER	3/16 (18.8%)		2/11 (18.2%)
INSOMNIA	8/16 (50%)		5/11 (45.5%)
INTERMITTENT ARTHRALGIA	1/16 (6.3%)		0/11 (0%)
INTERMITTENT CHEST PAIN	1/16 (6.3%)		0/11 (0%)
INTERMITTENT INSOMNIA	1/16 (6.3%)		0/11 (0%)
INTERMITTENT MIGRAINES	1/16 (6.3%)		0/11 (0%)
INTERMITTENT SORE THROAT	1/16 (6.3%)		0/11 (0%)
JOINT PAIN	1/16 (6.3%)		0/11 (0%)
LEFT SHOULDER PAIN	0/16 (0%)		1/11 (9.1%)
LIMBIC ENCEPHALITIS (CHARACTERIZED BY DROWSINESS, HALLUCINATIONS, LOSS OF SHORT TERM MEMORY, CONFUSI	1/16 (6.3%)		0/11 (0%)
LT SHOULDER PAIN	0/16 (0%)		1/11 (9.1%)
MUSCULOSKELATAL CHEST PAIN	0/16 (0%)		1/11 (9.1%)
NIGHT SWEATS	1/16 (6.3%)		1/11 (9.1%)
PAIN (CHEST)	1/16 (6.3%)		0/11 (0%)
PAIN - RIGHT CHEST INCISIONAL	0/16 (0%)		1/11 (9.1%)
PAIN - RIGHT LUNG	1/16 (6.3%)		0/11 (0%)
PAIN - RIGHT SHOULDER	0/16 (0%)		1/11 (9.1%)
PAIN - RIGHT UPPER CHEST	1/16 (6.3%)		0/11 (0%)
PANIC ATTACK INTERMITENT	1/16 (6.3%)		0/11 (0%)
RIGHT HIP PAIN	0/16 (0%)		1/11 (9.1%)
RIGHT SHOULDER AND BACK PAIN	0/16 (0%)		1/11 (9.1%)
RIGHT-SIDED CHEST PAIN	0/16 (0%)		1/11 (9.1%)
RUNNING NOSE	2/16 (12.5%)		0/11 (0%)
RUNNY NOSE	1/16 (6.3%)		0/11 (0%)
SHOULDER PAIN	1/16 (6.3%)		0/11 (0%)
SINUS CONGESTION	1/16 (6.3%)		0/11 (0%)
SINUS DRAINAGE	2/16 (12.5%)		1/11 (9.1%)
SORE THROAT	4/16 (25%)		0/11 (0%)
STOMACH PAIN	2/16 (12.5%)		0/11 (0%)
Infections and infestations
BRONCHITIS	1/16 (6.3%)		0/11 (0%)
FLUSHING (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
FUNGAL INFECTION ON ANKLES	1/16 (6.3%)		0/11 (0%)
INFECTION	1/16 (6.3%)		0/11 (0%)
PHARGNGITIS	1/16 (6.3%)		0/11 (0%)
SINUS INFECTIN	1/16 (6.3%)		0/11 (0%)
SINUS INFECTION	1/16 (6.3%)		0/11 (0%)
SINUSITIS	1/16 (6.3%)		0/11 (0%)
SINUSITIS (SINUS INFECTION)	1/16 (6.3%)		0/11 (0%)
STAPH INFECTION	1/16 (6.3%)		0/11 (0%)
STREP INFLUENZA	1/16 (6.3%)		0/11 (0%)
Investigations
ELEVATED AST	1/16 (6.3%)		0/11 (0%)
ELEVATED LFT'S	1/16 (6.3%)		0/11 (0%)
ELEVATED LIVER ENZYMES	0/16 (0%)		1/11 (9.1%)
ELEVATED LIVER FUNC. TEST	1/16 (6.3%)		0/11 (0%)
ELEVATED LIVER FUNCTION TEST	2/16 (12.5%)		0/11 (0%)
HYPERBILIRUBINEMIA	1/16 (6.3%)		0/11 (0%)
HYPERBILRUBEMIA	1/16 (6.3%)		0/11 (0%)
HYPERGLYCEMIA	0/16 (0%)		1/11 (9.1%)
HYPERLIPIDEMIA	0/16 (0%)		1/11 (9.1%)
Metabolism and nutrition disorders
ANOREXIA	7/16 (43.8%)		6/11 (54.5%)
Musculoskeletal and connective tissue disorders
ANKLE/KNEE PAIN	1/16 (6.3%)		0/11 (0%)
ARTHRITIC PAIN	1/16 (6.3%)		0/11 (0%)
BACK PAIN	0/16 (0%)		2/11 (18.2%)
BACK PAIN (INTERMITTENT FOR YEARS)	1/16 (6.3%)		0/11 (0%)
BONE PAIN (LEGS)	0/16 (0%)		1/11 (9.1%)
CHEST PAIN (MUSCULOSKELATAL)	1/16 (6.3%)		0/11 (0%)
CHEST TIGHTNESS	1/16 (6.3%)		0/11 (0%)
CYST ON LEFT BUTTOCK	1/16 (6.3%)		0/11 (0%)
GOUT	0/16 (0%)		1/11 (9.1%)
HIP PAIN	1/16 (6.3%)		0/11 (0%)
PAIN - BACK MIDDLE	1/16 (6.3%)		0/11 (0%)
PAIN - HANDS - INTERMITTAT BURNING SENSATION	0/16 (0%)		1/11 (9.1%)
Nervous system disorders
HEADACHE	2/16 (12.5%)		0/11 (0%)
HEADACHES	1/16 (6.3%)		1/11 (9.1%)
HEADACHES - INTERMITTENT	1/16 (6.3%)		0/11 (0%)
INTERMITTENT TINGLING IN FINGERS AND TOES	1/16 (6.3%)		0/11 (0%)
LEG WEAKNESS	0/16 (0%)		1/11 (9.1%)
NEUROPATHY	1/16 (6.3%)		0/11 (0%)
NEUROPATHY (FEET, TOES, & ELBOW NUMB)	0/16 (0%)		1/11 (9.1%)
NEUROPATHY (FINGERTIPS)	1/16 (6.3%)		0/11 (0%)
NEUROPATHY - FINGERS	2/16 (12.5%)		1/11 (9.1%)
NEUROPATHY - FINGERS AND TOES	1/16 (6.3%)		0/11 (0%)
NEUROPATHY - HANDS	1/16 (6.3%)		0/11 (0%)
NEUROPATHY - TOES	0/16 (0%)		1/11 (9.1%)
NEUROPATHY, SENSORY: TOES	1/16 (6.3%)		0/11 (0%)
NEUROPATHY-SENSORY- BALL OF FEET	0/16 (0%)		1/11 (9.1%)
NUMBNESS - FEET	1/16 (6.3%)		0/11 (0%)
NUMBNESS - LEFT CHEST INCISIONAL	0/16 (0%)		1/11 (9.1%)
NUMBNESS OF BOTH LEGS	1/16 (6.3%)		0/11 (0%)
RIGHT FOOT TREMOR	1/16 (6.3%)		0/11 (0%)
RIGHT HAND TREMOR	1/16 (6.3%)		0/11 (0%)
SENSORY NEUROPATHY - BOTTOM OF FEET NUMB	1/16 (6.3%)		0/11 (0%)
Psychiatric disorders
ANXIETY	5/16 (31.3%)		2/11 (18.2%)
ANXIETY (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
DEPRESSION	1/16 (6.3%)		0/11 (0%)
IRRITIABLE	1/16 (6.3%)		0/11 (0%)
MOOD - DEPRESSION	1/16 (6.3%)		0/11 (0%)
Renal and urinary disorders
NOCTURIA	2/16 (12.5%)		1/11 (9.1%)
PAIN - KIDNEY AREA LEFT AND RIGHT	1/16 (6.3%)		0/11 (0%)
POLYURIA	0/16 (0%)		1/11 (9.1%)
URINARY INCONTINENCE	1/16 (6.3%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
ASTHMA (BRONCHIOSPASM)	1/16 (6.3%)		0/11 (0%)
ATCLECTASIS	0/16 (0%)		1/11 (9.1%)
COUGH	8/16 (50%)		6/11 (54.5%)
HICCUPS	0/16 (0%)		1/11 (9.1%)
HOARSENESS	0/16 (0%)		3/11 (27.3%)
HYPOXIA	0/16 (0%)		2/11 (18.2%)
INTERMITTENT HICCUPS	1/16 (6.3%)		0/11 (0%)
PLEURAL EFFUSION	0/16 (0%)		1/11 (9.1%)
SLEEP APNEA	0/16 (0%)		1/11 (9.1%)
UPPER RESPIRATORY INFECTION	0/16 (0%)		1/11 (9.1%)
Skin and subcutaneous tissue disorders
ALOPECIA	2/16 (12.5%)		2/11 (18.2%)
ALOPECIA - THINNING	1/16 (6.3%)		0/11 (0%)
DERMATITIS BILATERALLY	0/16 (0%)		1/11 (9.1%)
HIVES	1/16 (6.3%)		0/11 (0%)
HYPERPIGMENTATION OF PALMS OF HANDS	1/16 (6.3%)		0/11 (0%)
PRURITIUS/ITCHING	1/16 (6.3%)		0/11 (0%)
PRURITUS	4/16 (25%)		1/11 (9.1%)
PRURITUS/ITCHING	3/16 (18.8%)		2/11 (18.2%)
PRURITUS/ITCHING (INTERMITTENT)	2/16 (12.5%)		0/11 (0%)
RASH	6/16 (37.5%)		1/11 (9.1%)
RASH (INFUSION SITE)	1/16 (6.3%)		0/11 (0%)
RASH (INTERMITTENT)	1/16 (6.3%)		0/11 (0%)
RASH (LEFT CHEST)	0/16 (0%)		1/11 (9.1%)
RASH (NECK) INTERMITTENT	1/16 (6.3%)		0/11 (0%)
RASH - NECK AND ABDOMEN AREA	0/16 (0%)		1/11 (9.1%)
RASH - RED FACE AND ARMS	0/16 (0%)		1/11 (9.1%)
SKIN - RED, RAISED RASH ON NECK AND UPPER CHEST	0/16 (0%)		1/11 (9.1%)
SURGERY (REMOVAL SKIN CANCER) FACE & RIGHT ARM	0/16 (0%)		1/11 (9.1%)
UPPER CHEST ITCHING	0/16 (0%)		1/11 (9.1%)
Vascular disorders
BLOOD CLOT-LEFT ARM	1/16 (6.3%)		0/11 (0%)
HYPERTENSION	0/16 (0%)		1/11 (9.1%)
INTERMITTENT BLOODY NOSE	1/16 (6.3%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.