CA225200: PhII ICb With/Without Erbitux in MBC Pts

• Sponsor: US Oncology Research (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00248287
• Collaborator: Bristol-Myers Squibb (Industry), Pfizer (Industry)
• Enrollment: 154
• Locations: 59
• Arms: 2
• Anticipated Duration (Months): 208.1
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Irinotecan + Carboplatin; Drug: irinotecan + Carboplatin + erbitux	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer
• Actual Study Start Date: Jul 28, 2005
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)	Drug: Irinotecan + Carboplatin; irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
Experimental: Arm 2 irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)	Drug: irinotecan + Carboplatin + erbitux; irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2

Outcome Measures

Primary Outcome Measures

1. Objective Response Rates (ORR) [2 years]

   To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Secondary Outcome Measures

1. Duration of Response [From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.]

   The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

2. Median Time of Progression-free Survival (PFS) [2 years]

   PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

3. Median Overall Survival (OS) [2 years]

   OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

Eligibility Criteria

Criteria

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

INCLUSION CRITERIA:

Male and female patients will be eligible for inclusion in this study if they meet all of the following criteria:

• Has cytologically or pathologically confirmed, breast cancer with documented HER2+ (positive) (3+ by IHC or FISH+) or HER2- (negative) disease. ER, PR, and HER2 status must be documented in the electronic Case Report Form (eCRF) NOTE: Patients whose breast cancers are HER2 (2+) by IHC must undergo FISH testing to confirm HER2+ (positive) status.

• Has clinically confirmed Stage IV metastatic breast cancer (MBC)

• Has undergone prior Herceptin therapy if breast cancer is HER2+ (positive)

• Has measurable MBC as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

NOTE: Ascites, pleural effusion, and bone metastases are not considered measurable.

• Has had up to 1 prior chemotherapy regimens for metastatic disease. Previously untreated disease is permitted.

• Has had no prior treatment with irinotecan, carboplatin, or cisplatin

• Has an ECOG Performance Status (PS) 0-2

• Is greater than 18 years of age

• Please see protocol for specific details regarding appropriate laboratory values for inclusion to the study.

• Any prior radiation therapy has been completed > 2 weeks prior to the start of study treatment

NOTE: Previously irradiated lesions will not be evaluable; however, these patients will still be eligible. Patients must have at least 1 measurable lesion at baseline.

• Has had a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential). A pregnancy test is also required within 7 days of Dose 1.

• If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 6 months thereafter.

• Has signed a Patient Informed Consent Form

• Has signed a Patient Authorization Form (HIPAA)

• Has paraffin-embedded breast cancer tissue (either paraffin blocks or 20 unstained slides) available for analysis of EGFR, cytokeratin, and other biological markers. These samples will be sent to the Molecular Profiling Institute (MPI; see Appendix VII).

NOTE: Availability of samples should be confirmed prior to randomization (at latest, prior to first dose).

EXCLUSION CRITERIA:

• Has Stage I-III breast cancer or nonmeasurable metastatic breast cancer, or any disease other than that described in inclusion criterion #1

• Has received prior treatment with irinotecan, carboplatin, or cisplatin

• Is receiving any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)

• Has received prior therapy which specifically and directly targets the EGFR pathway. Prior Herceptin is required for HER2+ patients.

• Has had prior severe infusion reaction to a monoclonal antibody

• Has received organ allograft(s) other than corneal, bone, or skin

• Has clinically significant uncontrolled cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmias not well-controlled with medication) or has had a myocardial infarction < 12 months

• Has ongoing peripheral neuropathy > Grade I

• Has evidence of symptomatic or untreated central nervous system (CNS) metastases (unless CNS metastases have been irradiated). Chronic steroid treatment for the treatment of CNS metastases must have been discontinued for greater than 4 weeks prior to study enrollment.

• Has any other significant comorbidity that, in the opinion of the clinical investigator, might compromise any aspect of the study

• Has active or uncontrolled infection

• Has acute hepatitis or is known to be HIV positive

• Has a history of other malignancy within the last 5 years which could affect the diagnosis or assessment of MBC, with the exception of carcinoma of the cervix in situ, carcinoma of the bladder in situ, and basal cell carcinoma

• Has previously completed a chemotherapy regimen within 3 weeks prior to the start of study treatment, or has related toxicities unresolved prior to the start of study treatment

NOTE: If patient was receiving prior weekly or daily chemotherapy, he/she may begin study therapy 2 weeks after stopping prior therapy provided all toxicities have resolved; peripheral neuropathy must be less than Grade I as per exclusion criterion #8 above.

• Has had major surgery within 3 weeks from the start of study treatment, without complete recovery

• Has participated in any investigational drug study within 4 weeks preceding the start of study treatment

• Has received a concurrent immunotherapy or hormonal anticancer agent within 2 weeks prior to the start of the study treatment

• Is receiving a tyrosine kinase inhibitor (ie, IressaTM)

• Has had any prior stem cell or bone marrow transplant for any prior hematologic malignancy

• Is pregnant or lactating

• Is unable to comply with the requirements of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Hematology and Oncology	Birmingham	Alabama	United States	35205
2	Hematology Oncology Asscociates	Phoenix	Arizona	United States	85012
3	Northern AZ Hematology & Oncology Assoc	Sedona	Arizona	United States	86336
4	Rocky Mountain Cancer Center-Rose	Denver	Colorado	United States	80220
5	Northwestern Connecticut Oncology Hematology Associates	Torrington	Connecticut	United States	06790
6	Melbourne Internal Medicine Associates	Melbourne	Florida	United States	32901
7	Florida Cancer Institute	New Port Richey	Florida	United States	34655
8	Ocala Oncology Center	Ocala	Florida	United States	34474
9	Cancer Centers of Florida, P.A.	Ocoee	Florida	United States	34761
10	Hematology Oncology Associates of IL	Chicago	Illinois	United States	60611
11	Central Indiana Cancer Center	Indianapolis	Indiana	United States	46227
12	Kansas City Cancer-Southwest	Overland Park	Kansas	United States	66210
13	Maryland Oncology Hematology, P.A.	Columbia	Maryland	United States	21044
14	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
15	Missouri Cancer Associates	Columbia	Missouri	United States	65201
16	Arch Medical Services, Inc	Saint Louis	Missouri	United States	63141
17	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89109
18	NH Oncology-Hematology PA	Hooksett	New Hampshire	United States	03106
19	Hematology-Oncology Associates of NNJ, P.A.	Morristown	New Jersey	United States	07960
20	Summit Medical Group	Summit	New Jersey	United States	07901
21	New York Oncology Hematology, P.C.	Albany	New York	United States	12208
22	New York Oncology Hematology, PC	Rexford	New York	United States	12148
23	Interlakes Oncology Hematology, PC	Rochester	New York	United States	14623
24	Raleigh Hematology Oncology Clinic	Cary	North Carolina	United States	27511
25	Greater Dayton Cancer Center	Kettering	Ohio	United States	45409
26	Willamette Valley Cancer Center	Eugene	Oregon	United States	97401
27	Cancer Center of the Carolinas, Seneca	Seneca	South Carolina	United States	29672
28	Texas Cancer Center-Abilene(South)	Abilene	Texas	United States	79606
29	Texas Cancer Center	Arlington	Texas	United States	76014
30	Texas Oncology Cancer Center	Austin	Texas	United States	78731
31	Mamie McFaddin Ward Cancer Center	Beaumont	Texas	United States	77702
32	Texas Oncology, P.A. - Bedford	Bedford	Texas	United States	76022
33	Texas Cancer Center at Medical City	Dallas	Texas	United States	75230
34	Texas Oncology, P.A.	Dallas	Texas	United States	75231
35	The Texas Cancer Center	Dallas	Texas	United States	75237
36	Texas Oncology, P.A.	Dallas	Texas	United States	75246
37	Texas Oncology Center - Denton	Denton	Texas	United States	76210
38	El Paso Cancer Treatment Ctr	El Paso	Texas	United States	79915
39	Texas Oncology, P.A.	Fort Worth	Texas	United States	76104
40	San Antonio Tumor & Blood Clinic	Fredericksburg	Texas	United States	78624
41	Texas Oncology, P.A.	Houston	Texas	United States	77024
42	Longview Cancer Center	Longview	Texas	United States	75601
43	South Texas Cancer Center-McAllen	McAllen	Texas	United States	78503
44	Texas Cancer Center of Mesquite	Mesquite	Texas	United States	75150
45	Allison Cancer Center	Midland	Texas	United States	79701
46	HOAST - New Braunfels	New Braunfels	Texas	United States	78131
47	West Texas Cancer Center	Odessa	Texas	United States	79761
48	Paris Regional Cancer Center	Paris	Texas	United States	75460
49	Texas Cancer Center-Sherman	Sherman	Texas	United States	75090
50	Texas Oncology Cancer Center-Sugar Land	Sugar Land	Texas	United States	77479
51	Tyler Cancer Center	Tyler	Texas	United States	75702
52	Waco Cancer Care and Research Center	Waco	Texas	United States	76712
53	Virginia Oncology Associates	Norfolk	Virginia	United States	23505
54	Onc and Hem Associates of SW VA, Inc.	Salem	Virginia	United States	24153
55	Puget Sound Cancer Center-Emonds	Edmonds	Washington	United States	98026
56	Puget Sound Cancer Center-Seattle	Seattle	Washington	United States	98133
57	Cancer Care Northwest-South	Spokane	Washington	United States	99202
58	Northwest Cancer Specialists-Vancouver	Vancouver	Washington	United States	98684
59	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington	United States	98902

Sponsors and Collaborators

• US Oncology Research
• Bristol-Myers Squibb
• Pfizer

Investigators

• Principal Investigator: Joyce A. O'Shaughnessy, MD, US Oncology Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 12, 2010

More Information

Publications

None provided.

• Responsible Party: US Oncology Research
• ClinicalTrials.gov Identifier: NCT00248287
• Other Study ID Numbers: 04070; CA225200
• First Posted: Nov 3, 2005
• Last Update Posted: Dec 28, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Breast Neoplasms; Carboplatin; Irinotecan; Cetuximab

Study Results

Participant Flow

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab
Period Title: Overall Study
STARTED	75	79
COMPLETED	51	60
NOT COMPLETED	24	19

Baseline Characteristics

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab	Total
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab	Total of all reporting groups
Overall Participants	75	79	154
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.7 (11.4)	54.9 (10.7)	54.3 (11.0)
Sex: Female, Male (Count of Participants)
Female	75 100%	79 100%	154 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	59 78.7%	69 87.3%	128 83.1%
Black	14 18.7%	8 10.1%	22 14.3%
Hispanic	2 2.7%	2 2.5%	4 2.6%
Region of Enrollment (participants) [Number]
United States	75 100%	79 100%	154 100%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rates (ORR)
Description	To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab
Measure Participants	66	71
Number (95% Confidence Interval) [Percentage of Participants]	36.4 48.5%	36.6 46.3%

2. Secondary Outcome

Title	Duration of Response
Description	The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame	From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.

Outcome Measure Data

Analysis Population Description

For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab
Measure Participants	24	26
Median (Full Range) [months]	5.4	6.0

3. Secondary Outcome

Title	Median Time of Progression-free Survival (PFS)
Description	PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab
Measure Participants	75	79
Median (95% Confidence Interval) [months]	4.4	4.6

4. Secondary Outcome

Title	Median Overall Survival (OS)
Description	OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Irinotecan+Carboplatin	Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin	Patients treated with Irinotecan + Carboplatin + Cetuximab
Measure Participants	75	79
Median (95% Confidence Interval) [months]	12.5	14.6

Adverse Events

Time Frame	During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description	For treated patients only, assessed at each treatment visit.
Arm/Group Title	Irinotecan+Carboplatin		Irinotecan+Carboplatin+Cetuximab
Arm/Group Description	Patients treated with Irinotecan + Carboplatin		Patients treated with Irinotecan + Carboplatin + Cetuximab
All Cause Mortality
	Irinotecan+Carboplatin		Irinotecan+Carboplatin+Cetuximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/75 (1.3%)		0/79 (0%)
Serious Adverse Events
	Irinotecan+Carboplatin		Irinotecan+Carboplatin+Cetuximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/75 (18.7%)		18/79 (22.8%)
Blood and lymphatic system disorders
ANEMIA	1/75 (1.3%)	1	1/79 (1.3%)	1
FEBRILE NEUTROPENIA	0/75 (0%)	0	2/79 (2.5%)	2
NEUTROPENIA	3/75 (4%)	3	2/79 (2.5%)	2
Cardiac disorders
CONGESTIVE HEART FAILURE	0/75 (0%)	0	1/79 (1.3%)	1
Gastrointestinal disorders
ABDOMINAL PAIN	0/75 (0%)	0	1/79 (1.3%)	1
DEHYDRATION	8/75 (10.7%)	8	6/79 (7.6%)	6
DIARRHEA	5/75 (6.7%)	5	9/79 (11.4%)	10
NAUSEA	1/75 (1.3%)	1	2/79 (2.5%)	2
NAUSEA AND VOMITING	1/75 (1.3%)	1	1/79 (1.3%)	1
VOMITING	0/75 (0%)	0	1/79 (1.3%)	1
General disorders
CONFUSION	1/75 (1.3%)	1	0/79 (0%)	0
FEVER	1/75 (1.3%)	1	0/79 (0%)	0
WEAKNESS GENERALIZED	2/75 (2.7%)	2	0/79 (0%)	0
Immune system disorders
ALLERGIC REACTION	1/75 (1.3%)	1	0/79 (0%)	0
ANAPHYLAXIS	1/75 (1.3%)	1	0/79 (0%)	0
Infections and infestations
BACTERIAL RESISTANCE	1/75 (1.3%)	1	0/79 (0%)	0
SEPSIS	0/75 (0%)	0	2/79 (2.5%)	2
Metabolism and nutrition disorders
HYPERBILIRUBINEMIA	0/75 (0%)	0	1/79 (1.3%)	1
HYPOCALCEMIA	0/75 (0%)	0	1/79 (1.3%)	1
HYPOMAGNESEMIA	0/75 (0%)	0	2/79 (2.5%)	2
Respiratory, thoracic and mediastinal disorders
EMBOLISM PULMONARY	0/75 (0%)	0	1/79 (1.3%)	1
INFECTION UPPER RESPIRATORY	0/75 (0%)	0	1/79 (1.3%)	1
Skin and subcutaneous tissue disorders
HYPERSENSITIVITY REACTION (NOS)	0/75 (0%)	0	1/79 (1.3%)	1
REACTION INJECTION SITE (NOS)	0/75 (0%)	0	1/79 (1.3%)	1
Vascular disorders
HYPOTENSION	0/75 (0%)	0	1/79 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Irinotecan+Carboplatin		Irinotecan+Carboplatin+Cetuximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/75 (97.3%)		79/79 (100%)
Blood and lymphatic system disorders
ANEMIA	47/75 (62.7%)	189	40/79 (50.6%)	132
EDEMA	2/75 (2.7%)	3	4/79 (5.1%)	6
LEUCOPENIA	29/75 (38.7%)	177	32/79 (40.5%)	170
LYMPHOPENIA	5/75 (6.7%)	39	5/79 (6.3%)	24
NEUTROPENIA	53/75 (70.7%)	242	56/79 (70.9%)	257
THROMBOCYTOPENIA	39/75 (52%)	138	32/79 (40.5%)	90
Gastrointestinal disorders
ABDOMINAL PAIN	11/75 (14.7%)	13	19/79 (24.1%)	30
ANOREXIA	18/75 (24%)	23	19/79 (24.1%)	23
CONSTIPATION	15/75 (20%)	20	11/79 (13.9%)	11
DEHYDRATION	9/75 (12%)	9	14/79 (17.7%)	20
DIARRHEA	50/75 (66.7%)	91	58/79 (73.4%)	130
GASTROESOPHAGEAL REFLUX	10/75 (13.3%)	12	11/79 (13.9%)	13
NAUSEA	55/75 (73.3%)	102	47/79 (59.5%)	90
STOMATITIS	3/75 (4%)	3	5/79 (6.3%)	6
VOMITING	30/75 (40%)	38	34/79 (43%)	50
General disorders
FATIGUE	45/75 (60%)	105	51/79 (64.6%)	110
FEVER	9/75 (12%)	10	2/79 (2.5%)	2
HEADACHE	2/75 (2.7%)	2	6/79 (7.6%)	8
PAIN	6/75 (8%)	7	3/79 (3.8%)	3
WEAKNESS	4/75 (5.3%)	7	10/79 (12.7%)	14
WEIGHT LOSS	4/75 (5.3%)	5	12/79 (15.2%)	17
Immune system disorders
ALLERGIC REACTION	1/75 (1.3%)	1	5/79 (6.3%)	7
Infections and infestations
MUCOSITIS	7/75 (9.3%)	8	4/79 (5.1%)	4
Metabolism and nutrition disorders
AST INCREASED	2/75 (2.7%)	4	6/79 (7.6%)	9
HYPOKALEMIA	10/75 (13.3%)	14	14/79 (17.7%)	26
HYPOMAGNESAEMIA	11/75 (14.7%)	30	22/79 (27.8%)	43
PHOSPHATASE ALKALINE INCREASED	2/75 (2.7%)	3	4/79 (5.1%)	6
Musculoskeletal and connective tissue disorders
MYALGIA	2/75 (2.7%)	12	4/79 (5.1%)	7
Nervous system disorders
DIZZINESS	6/75 (8%)	7	9/79 (11.4%)	16
NEUROPATHY	6/75 (8%)	17	8/79 (10.1%)	11
PARESTHESIA	2/75 (2.7%)	2	4/79 (5.1%)	4
Respiratory, thoracic and mediastinal disorders
COUGH	3/75 (4%)	3	7/79 (8.9%)	9
SHORTNESS OF BREATH	4/75 (5.3%)	5	5/79 (6.3%)	7
Skin and subcutaneous tissue disorders
ACNE	0/75 (0%)	0	5/79 (6.3%)	5
ALOPECIA	20/75 (26.7%)	23	27/79 (34.2%)	29
DRY SKIN	4/75 (5.3%)	4	19/79 (24.1%)	20
HOT FLASHES	5/75 (6.7%)	6	1/79 (1.3%)	1
PRURITUS	0/75 (0%)	0	4/79 (5.1%)	6
RASH	14/75 (18.7%)	22	56/79 (70.9%)	105
Vascular disorders
HYPOTENSION	4/75 (5.3%)	4	2/79 (2.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.