A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03368859
• Collaborator: (none)
• Enrollment: 70
• Locations: 65
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Leucovorin; Drug: Fluorouracil - bolus; Drug: Bevacizumab; Drug: Fluorouracil - infusion; Drug: ABT-165; Drug: Irinotecan	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
• Actual Study Start Date: Mar 20, 2018
• Actual Primary Completion Date: Dec 18, 2019
• Actual Study Completion Date: Dec 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-165 plus FOLFIRI ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).	Drug: Leucovorin; Intravenous; Other Names: Folinic Acid ; Drug: Fluorouracil - bolus; Intravenous; Other Names: 5-FU ; Drug: Fluorouracil - infusion; Intravenous; Other Names: 5-FU ; Drug: ABT-165; Intravenous; Drug: Irinotecan; Intravenous; Other Names: Irinotecan hydrochloride
Active Comparator: Bevacizumab plus FOLFIRI Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).	Drug: Leucovorin; Intravenous; Other Names: Folinic Acid ; Drug: Fluorouracil - bolus; Intravenous; Other Names: 5-FU ; Drug: Bevacizumab; Intravenous; Other Names: Avastin ; Drug: Fluorouracil - infusion; Intravenous; Other Names: 5-FU ; Drug: Irinotecan; Intravenous; Other Names: Irinotecan hydrochloride

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively]

   PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.

Secondary Outcome Measures

1. Objective Response Rate (ORR) [From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively]

   ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

2. Overall Survival (OS) [Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively]

   OS is defined as the time from randomization until death from any cause.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.

• Primary tumor has been resected > 3 months prior to randomization.

• At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

• Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.

• Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

• Any prior therapy with irinotecan

• Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2

• Clinically significant conditions that increase the risk for antiangiogenic therapy.

• History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ironwood Cancer & Res Ctr /ID# 200044	Chandler	Arizona	United States	85224-5665
2	Highlands Oncology Group /ID# 169289	Fayetteville	Arkansas	United States	72703-4005
3	City of Hope /ID# 200501	Duarte	California	United States	91010
4	St. Joseph Heritage Healthcare /ID# 200100	Fullerton	California	United States	92835
5	USC Norris Cancer Center /ID# 200410	Los Angeles	California	United States	90033
6	Hoag Memorial Hosp Presbyterian /ID# 202661	Newport Beach	California	United States	92663
7	Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488	Redondo Beach	California	United States	90277-3036
8	UC Davis Comprehensive Cancer Center - Main /ID# 207227	Sacramento	California	United States	95817
9	Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215	San Luis Obispo	California	United States	93401-7068
10	Central Coast Medical Oncology /ID# 200227	Santa Maria	California	United States	93454-5909
11	University of California, Los /ID# 169294	Santa Monica	California	United States	90404
12	Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801	Aurora	Colorado	United States	80014
13	Georgetown University Hospital /ID# 202903	Washington	District of Columbia	United States	20007
14	Florida Cancer Specialist - South /ID# 203796	Fort Myers	Florida	United States	33901-8108
15	Florida Cancer Specialists-Panhandle /ID# 203787	Tallahassee	Florida	United States	32308-5304
16	IACT Health /ID# 169292	Columbus	Georgia	United States	31904-8946
17	Ingalls Memorial Hosp /ID# 169892	Harvey	Illinois	United States	60426
18	Illinois Cancer Care, PC /ID# 202189	Peoria	Illinois	United States	61615
19	Fort Wayne Medical Oncology /ID# 201616	Fort Wayne	Indiana	United States	46804
20	Cancer Center of Kansas /ID# 200627	Wichita	Kansas	United States	67214
21	Norton Cancer Institute /ID# 200674	Louisville	Kentucky	United States	40207
22	Ochsner Clinic Foundation-New Orleans /ID# 169291	New Orleans	Louisiana	United States	70121
23	Whiteside Institute for Clinic /ID# 200802	Duluth	Minnesota	United States	55805
24	Mmcorc /Id# 202099	Saint Louis Park	Minnesota	United States	55416
25	Washington University School /ID# 200621	Saint Louis	Missouri	United States	63108
26	University of Nebraska /ID# 203195	Omaha	Nebraska	United States	68198
27	The Valley Hospital /ID# 169999	Paramus	New Jersey	United States	07652
28	Duke University Medical Center /ID# 169657	Durham	North Carolina	United States	27710-3000
29	Fairview Hospital - Moll Pavilion /ID# 205910	Cleveland	Ohio	United States	44111-5605
30	Cleveland Clinic Main Campus /ID# 200325	Cleveland	Ohio	United States	44195
31	Hillcrest Hospital /ID# 205911	Mayfield Heights	Ohio	United States	44124
32	INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831	Oklahoma City	Oklahoma	United States	73109-3411
33	INTEGRIS Cancer Institute /ID# 200832	Oklahoma City	Oklahoma	United States	73142
34	Oregon Health and Science University /ID# 170807	Portland	Oregon	United States	97239
35	Thomas Jefferson University /ID# 200833	Philadelphia	Pennsylvania	United States	19107-4414
36	UPMC Hillman Cancer Ctr /ID# 200672	Pittsburgh	Pennsylvania	United States	15232
37	Greenville Hospital System /ID# 203021	Greenville	South Carolina	United States	29605
38	Tennessee Oncology-Nashville Centennial /ID# 203424	Nashville	Tennessee	United States	37203-1632
39	Tennessee Oncology, PLLC /ID# 203581	Nashville	Tennessee	United States	37203
40	Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112	Dallas	Texas	United States	75235-7709
41	UTSW-Dallas /ID# 204031	Dallas	Texas	United States	75390
42	Millennium Oncology /ID# 204925	Houston	Texas	United States	77090-1243
43	Virginia Cancer Specialists /ID# 169293	Fairfax	Virginia	United States	22031
44	Kadlec Clinic Hematology and O /ID# 170811	Kennewick	Washington	United States	99336
45	Medical Oncology Associates /ID# 169290	Spokane	Washington	United States	99208
46	Univ of Wisconsin Hosp/Clinics /ID# 200424	Madison	Wisconsin	United States	53792-0001
47	UZ Gent /ID# 200691	Gent	Oost-Vlaanderen	Belgium	9000
48	Imelda Ziekenhuis /ID# 200693	Bonheiden		Belgium	2820
49	Cliniques universitaires Saint /ID# 203101	Brussels		Belgium	1200
50	UZ Antwerp /ID# 200694	Edegem		Belgium	2650
51	UZ Leuven /ID# 200001	Leuven		Belgium	3000
52	Hospital Maisonneuve-Rosemont /ID# 171590	Montreal	Quebec	Canada	H1T 2M4
53	Jewish General Hospital /ID# 171584	Montreal	Quebec	Canada	H3T 1E2
54	National Cancer Center /ID# 170879	Goyang	Gyeonggido	Korea, Republic of	10408
55	Samsung Medical Center /ID# 170875	Seoul	Seoul Teugbyeolsi	Korea, Republic of	06351
56	Seoul National University Hospital /ID# 170878	Seoul		Korea, Republic of	03080
57	Asan Medical Center /ID# 170877	Seoul		Korea, Republic of	05505
58	Hospital Universitario Vall d'Hebron /ID# 200186	Barcelona		Spain	08035
59	Hospital General Universitario Gregorio Maranon /ID# 200189	Madrid		Spain	28007
60	Hospital Clinico Universitario San Carlos /ID# 201721	Madrid		Spain	28040
61	Hospital Universitario Fundacion Jimenez Diaz /ID# 200187	Madrid		Spain	28040
62	Hospital Universitario HM Sanchinarro /ID# 200190	Madrid		Spain	28050
63	National Taiwan Univ Hosp /ID# 170677	Taipei City	Taipei	Taiwan	10002
64	Taichung Veterans General Hosp /ID# 170123	Taichung City		Taiwan	40705
65	Taipei Veterans General Hosp /ID# 170675	Taipei City		Taiwan	11217

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 7, 2019

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03368859
• Other Study ID Numbers: M14-064; 2017-003669-87
• First Posted: Dec 11, 2017
• Last Update Posted: Feb 9, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: cancer; colorectal cancer; ABT-165; FOLFIRI; Bevacizumab; bowel cancer; metastatic colorectal cancer; metastatic colorectal
• Additional relevant MeSH terms: Colorectal Neoplasms; Leucovorin; Bevacizumab; Fluorouracil; Irinotecan

Study Results

Participant Flow

Recruitment Details	The intent to treat (ITT) population included all randomized participants and was used for all efficacy and baseline analyses.
Pre-assignment Detail	A total of 70 participants were randomized to 1 of the 2 study treatments. Participants were grouped according to treatment as randomized.

Arm/Group Title	ABT-165 Plus FOLFIRI	Bevacizumab Plus FOLFIRI
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Period Title: Overall Study
STARTED	36	34
COMPLETED	0	0
NOT COMPLETED	36	34

Baseline Characteristics

Arm/Group Title	ABT-165 Plus FOLFIRI	Bevacizumab Plus FOLFIRI	Total
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Total of all reporting groups
Overall Participants	36	34	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.8 (11.41)	60.2 (10.19)	60.5 (10.76)
Sex: Female, Male (Count of Participants)
Female	15 41.7%	15 44.1%	30 42.9%
Male	21 58.3%	19 55.9%	40 57.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.6%	3 8.8%	5 7.1%
Not Hispanic or Latino	34 94.4%	31 91.2%	65 92.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	20 55.6%	20 58.8%	40 57.1%
Black or African American	2 5.6%	1 2.9%	3 4.3%
Asian	11 30.6%	11 32.4%	22 31.4%
American Indian or Alaska native	1 2.8%	0 0%	1 1.4%
Native Hawaiian or other Pacific Islander	1 2.8%	0 0%	1 1.4%
Missing	1 2.8%	2 5.9%	3 4.3%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Time Frame	Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT): includes all randomized participants.

Arm/Group Title	ABT-165 Plus FOLFIRI	Bevacizumab Plus FOLFIRI
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Measure Participants	36	34
Median (95% Confidence Interval) [Months]	3.78	7.36

2. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Time Frame	From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	ABT-165 Plus FOLFIRI	Bevacizumab Plus FOLFIRI
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Measure Participants	36	34
Number (95% Confidence Interval) [percentage of participants]	5.6 15.6%	14.7 43.2%

3. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is defined as the time from randomization until death from any cause.
Time Frame	Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	ABT-165 Plus FOLFIRI	Bevacizumab Plus FOLFIRI
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Measure Participants	36	34
Median (95% Confidence Interval) [Months]	7.95	NA

Adverse Events

Time Frame	Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Arm/Group Title	ABT-165 Plus FOLFIRI		Bevacizumab Plus FOLFIRI
Arm/Group Description	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity		Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
All Cause Mortality
	ABT-165 Plus FOLFIRI		Bevacizumab Plus FOLFIRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/34 (35.3%)		6/32 (18.8%)
Serious Adverse Events
	ABT-165 Plus FOLFIRI		Bevacizumab Plus FOLFIRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/34 (50%)		8/32 (25%)
Blood and lymphatic system disorders
ANAEMIA	1/34 (2.9%)	2	0/32 (0%)	0
FEBRILE NEUTROPENIA	2/34 (5.9%)	2	1/32 (3.1%)	1
NEUTROPENIA	1/34 (2.9%)	1	0/32 (0%)	0
Cardiac disorders
ATRIAL FIBRILLATION	1/34 (2.9%)	1	0/32 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN	1/34 (2.9%)	1	0/32 (0%)	0
ANAL HAEMORRHAGE	0/34 (0%)	0	1/32 (3.1%)	1
GASTRIC PERFORATION	0/34 (0%)	0	1/32 (3.1%)	1
GASTROINTESTINAL PERFORATION	1/34 (2.9%)	1	0/32 (0%)	0
ILEUS	1/34 (2.9%)	1	0/32 (0%)	0
INTESTINAL ISCHAEMIA	1/34 (2.9%)	1	0/32 (0%)	0
INTESTINAL PERFORATION	2/34 (5.9%)	2	0/32 (0%)	0
General disorders
ASTHENIA	1/34 (2.9%)	1	0/32 (0%)	0
DISEASE PROGRESSION	0/34 (0%)	0	1/32 (3.1%)	1
MULTIPLE ORGAN DYSFUNCTION SYNDROME	1/34 (2.9%)	1	0/32 (0%)	0
PYREXIA	1/34 (2.9%)	1	0/32 (0%)	0
Hepatobiliary disorders
BILE DUCT STENOSIS	0/34 (0%)	0	1/32 (3.1%)	1
Infections and infestations
ANAL ABSCESS	1/34 (2.9%)	1	0/32 (0%)	0
CELLULITIS	0/34 (0%)	0	1/32 (3.1%)	1
HEPATITIS B	0/34 (0%)	0	1/32 (3.1%)	1
PNEUMONIA	1/34 (2.9%)	1	0/32 (0%)	0
SEPSIS	2/34 (5.9%)	2	0/32 (0%)	0
SEPTIC SHOCK	1/34 (2.9%)	1	0/32 (0%)	0
Metabolism and nutrition disorders
DECREASED APPETITE	1/34 (2.9%)	1	0/32 (0%)	0
DEHYDRATION	0/34 (0%)	0	1/32 (3.1%)	1
HYPERCALCAEMIA	1/34 (2.9%)	1	0/32 (0%)	0
HYPOKALAEMIA	1/34 (2.9%)	1	0/32 (0%)	0
HYPOMAGNESAEMIA	1/34 (2.9%)	1	0/32 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION	3/34 (8.8%)	3	2/32 (6.3%)	2
Nervous system disorders
ENCEPHALOPATHY	1/34 (2.9%)	1	0/32 (0%)	0
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	1/34 (2.9%)	1	0/32 (0%)	0
PLEURAL EFFUSION	0/34 (0%)	0	1/32 (3.1%)	1
Vascular disorders
DEEP VEIN THROMBOSIS	1/34 (2.9%)	1	0/32 (0%)	0
Other (Not Including Serious) Adverse Events
	ABT-165 Plus FOLFIRI		Bevacizumab Plus FOLFIRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/34 (94.1%)		31/32 (96.9%)
Blood and lymphatic system disorders
ANAEMIA	3/34 (8.8%)	4	5/32 (15.6%)	10
LEUKOPENIA	5/34 (14.7%)	12	5/32 (15.6%)	7
NEUTROPENIA	14/34 (41.2%)	31	12/32 (37.5%)	32
THROMBOCYTOPENIA	3/34 (8.8%)	5	2/32 (6.3%)	2
Gastrointestinal disorders
ABDOMINAL DISTENSION	1/34 (2.9%)	1	2/32 (6.3%)	4
ABDOMINAL PAIN	6/34 (17.6%)	7	6/32 (18.8%)	7
ABDOMINAL PAIN UPPER	1/34 (2.9%)	1	4/32 (12.5%)	5
ANAL FISSURE	2/34 (5.9%)	2	0/32 (0%)	0
CONSTIPATION	8/34 (23.5%)	8	5/32 (15.6%)	10
DIARRHOEA	18/34 (52.9%)	23	15/32 (46.9%)	20
DRY MOUTH	1/34 (2.9%)	1	3/32 (9.4%)	3
DYSPEPSIA	1/34 (2.9%)	1	4/32 (12.5%)	4
FLATULENCE	0/34 (0%)	0	3/32 (9.4%)	3
HAEMATOCHEZIA	1/34 (2.9%)	1	2/32 (6.3%)	2
NAUSEA	18/34 (52.9%)	25	14/32 (43.8%)	19
RECTAL HAEMORRHAGE	0/34 (0%)	0	2/32 (6.3%)	3
STOMATITIS	7/34 (20.6%)	7	10/32 (31.3%)	14
TOOTH LOSS	2/34 (5.9%)	2	0/32 (0%)	0
TOOTHACHE	1/34 (2.9%)	1	2/32 (6.3%)	2
VOMITING	5/34 (14.7%)	12	9/32 (28.1%)	14
General disorders
ASTHENIA	2/34 (5.9%)	2	2/32 (6.3%)	2
CATHETER SITE PAIN	2/34 (5.9%)	2	0/32 (0%)	0
CHILLS	2/34 (5.9%)	2	0/32 (0%)	0
FATIGUE	14/34 (41.2%)	18	13/32 (40.6%)	24
MUCOSAL INFLAMMATION	1/34 (2.9%)	1	2/32 (6.3%)	8
NON-CARDIAC CHEST PAIN	0/34 (0%)	0	2/32 (6.3%)	2
OEDEMA PERIPHERAL	4/34 (11.8%)	4	0/32 (0%)	0
PYREXIA	3/34 (8.8%)	3	3/32 (9.4%)	3
Infections and infestations
NASOPHARYNGITIS	2/34 (5.9%)	2	1/32 (3.1%)	1
UPPER RESPIRATORY TRACT INFECTION	2/34 (5.9%)	2	1/32 (3.1%)	1
URINARY TRACT INFECTION	2/34 (5.9%)	2	0/32 (0%)	0
Injury, poisoning and procedural complications
FALL	3/34 (8.8%)	3	0/32 (0%)	0
INFUSION RELATED REACTION	1/34 (2.9%)	1	3/32 (9.4%)	3
Investigations
ALANINE AMINOTRANSFERASE INCREASED	0/34 (0%)	0	3/32 (9.4%)	3
ASPARTATE AMINOTRANSFERASE INCREASED	0/34 (0%)	0	5/32 (15.6%)	5
BLOOD ALKALINE PHOSPHATASE INCREASED	0/34 (0%)	0	4/32 (12.5%)	4
BLOOD CHOLESTEROL INCREASED	0/34 (0%)	0	2/32 (6.3%)	2
GAMMA-GLUTAMYLTRANSFERASE INCREASED	1/34 (2.9%)	1	3/32 (9.4%)	4
NEUTROPHIL COUNT DECREASED	4/34 (11.8%)	8	2/32 (6.3%)	5
PLATELET COUNT DECREASED	1/34 (2.9%)	1	3/32 (9.4%)	4
WEIGHT DECREASED	1/34 (2.9%)	1	3/32 (9.4%)	3
WHITE BLOOD CELL COUNT DECREASED	2/34 (5.9%)	2	2/32 (6.3%)	2
Metabolism and nutrition disorders
DECREASED APPETITE	8/34 (23.5%)	8	7/32 (21.9%)	9
DEHYDRATION	6/34 (17.6%)	6	3/32 (9.4%)	4
HYPERGLYCAEMIA	1/34 (2.9%)	2	2/32 (6.3%)	2
HYPERTRIGLYCERIDAEMIA	2/34 (5.9%)	2	2/32 (6.3%)	2
HYPOALBUMINAEMIA	2/34 (5.9%)	2	2/32 (6.3%)	2
HYPOKALAEMIA	5/34 (14.7%)	5	2/32 (6.3%)	3
HYPONATRAEMIA	3/34 (8.8%)	3	0/32 (0%)	0
Musculoskeletal and connective tissue disorders
BACK PAIN	0/34 (0%)	0	2/32 (6.3%)	2
MUSCULOSKELETAL PAIN	0/34 (0%)	0	2/32 (6.3%)	3
PAIN IN EXTREMITY	3/34 (8.8%)	3	1/32 (3.1%)	2
Nervous system disorders
DIZZINESS	7/34 (20.6%)	8	2/32 (6.3%)	2
DYSGEUSIA	3/34 (8.8%)	3	0/32 (0%)	0
HEADACHE	6/34 (17.6%)	6	4/32 (12.5%)	4
PERIPHERAL SENSORY NEUROPATHY	0/34 (0%)	0	3/32 (9.4%)	3
Psychiatric disorders
ANXIETY	4/34 (11.8%)	4	1/32 (3.1%)	1
DEPRESSION	0/34 (0%)	0	4/32 (12.5%)	4
INSOMNIA	0/34 (0%)	0	4/32 (12.5%)	4
Renal and urinary disorders
PROTEINURIA	2/34 (5.9%)	2	1/32 (3.1%)	1
URINARY RETENTION	2/34 (5.9%)	2	0/32 (0%)	0
Respiratory, thoracic and mediastinal disorders
COUGH	2/34 (5.9%)	2	4/32 (12.5%)	4
DYSPHONIA	2/34 (5.9%)	2	2/32 (6.3%)	2
DYSPNOEA	4/34 (11.8%)	5	2/32 (6.3%)	2
EPISTAXIS	2/34 (5.9%)	3	4/32 (12.5%)	4
HICCUPS	3/34 (8.8%)	3	2/32 (6.3%)	2
OROPHARYNGEAL PAIN	1/34 (2.9%)	1	3/32 (9.4%)	3
Skin and subcutaneous tissue disorders
ALOPECIA	6/34 (17.6%)	6	6/32 (18.8%)	6
HYPERHIDROSIS	1/34 (2.9%)	1	3/32 (9.4%)	3
Vascular disorders
HYPERTENSION	10/34 (29.4%)	15	4/32 (12.5%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.