BATON-BC: Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

• Sponsor: AVEO Pharmaceuticals, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01745367
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 30
• Locations: 54
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: Tivozanib Hydrochloride; Drug: paclitaxel; Drug: Placebo	Phase 2

Detailed Description

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.

Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).

All subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel v Placebo in Combination With Paclitaxel in Locally Recurrent and/or Metastatic Triple Negative Breast Cancer
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Placebo in combination with paclitaxel Placebo orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).	Drug: paclitaxel; Other Names: PTX ; Drug: Placebo
Experimental: Tivo in combination with paclitaxel 1.5 mg tivozanib hydrochloride orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).	Drug: Tivozanib Hydrochloride; Other Names: Tivozanib ; Drug: paclitaxel; Other Names: PTX

Outcome Measures

Primary Outcome Measures

1. Comparison of Progression-free Survival (PFS) of Subjects [approximately 24 months]

   PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

Secondary Outcome Measures

1. Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects [approximately 24 months]

   ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

2. Comparison of Overall Survival (OS) of Subjects [approximately 24 months]

   OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

3. Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel [approximately 24 months]

   Number of subjects with serious and non-serious adverse events.

4. Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination [approximately 24 months]

   PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.

5. Identification of Hypoxia Gene Signature [Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose]

   Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.

6. Measurement of Subjects' Quality of Life (QoL) [approximately 24 months]

   The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Locally recurrent or metastatic TNBC, defined as ER/PR <1%, HER2 0-1+, or 2+ with negative FISH

• Measurable disease per RECIST version 1.1

• ECOG performance status of 0 or 1

• Confirmed available archival tumor tissue.

Exclusion Criteria:

• More than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy

• Prior treatment with VEGF pathway targeted agent

• Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug

• Known history of central nervous system metastasis (subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable off steroids or enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment may be enrolled)

• Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders

• Significant serum chemistry or urinalysis abnormalities

• Significant cardiovascular disease, including: uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to administration of first dose of study drug; and symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.

• Severe peripheral neuropathy ≥ Grade 2

• Currently active second primary malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35005
2		Jacksonville	Florida	United States	32034
3		Miami	Florida	United States	33018
4		Atlanta	Georgia	United States	30301
5		Chicago	Illinois	United States	60007
6		Oak Lawn	Illinois	United States	60456
7		Fort Wayne	Indiana	United States	46774
8		Indianapolis	Indiana	United States	46077
9		Baltimore	Maryland	United States	21201
10		Boston	Massachusetts	United States	01841
11		Saint Louis	Missouri	United States	63101
12		Bronx	New York	United States	10453
13		New York	New York	United States	10001
14		Chapel Hill	North Carolina	United States	27514
15		Fargo	North Dakota	United States	58102
16		Charleston	South Carolina	United States	02129
17		Sioux Falls	South Dakota	United States	57101
18		Memphis	Tennessee	United States	37501
19		Dallas	Texas	United States	75001
20		Galveston	Texas	United States	77550
21		Port Macquarie	New South Wales	Australia
22		Woodville South	South Australia	Australia
23		Bentleigh	Victoria	Australia	3204
24		Newcastle		Australia
25		South Brisbane		Australia
26		St Leonards		Australia
27		Nassau		Bahamas
28		Calgary	Alberta	Canada
29		Edmonton	Alberta	Canada
30		Vancouver	British Columbia	Canada
31		Toronto	Ontario	Canada
32		Saint John		Canada
33		Berlin		Germany
34		Cologne		Germany
35		Hanau am Main		Germany	63454
36		Leipzig		Germany
37		Muenster		Germany
38		Tuebingen		Germany
39		Avellino		Italy
40		Milano		Italy
41		Roma		Italy
42		Torino		Italy
43		Viterbo		Italy
44		Seoul		Korea, Republic of
45		Barcelona		Spain
46		Madrid		Spain
47		Malaga		Spain
48		Sevilla		Spain
49		Kaohsiung		Taiwan
50		Taipei		Taiwan
51		Dnipropetrovsk		Ukraine
52		Donetsk		Ukraine
53		Uzhhorod		Ukraine
54		Vinnytsia		Ukraine

Sponsors and Collaborators

• AVEO Pharmaceuticals, Inc.
• Astellas Pharma Inc

Investigators

• Study Chair: Michael Needle, AVEO Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Aveo Pharmaceuticals, Inc. official web page

Publications

None provided.

• Responsible Party: AVEO Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01745367
• Other Study ID Numbers: AV-951-12-204; 2012-003507-35
• First Posted: Dec 10, 2012
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by AVEO Pharmaceuticals, Inc.: Tivozanib hydrochloride; triple negative breast cancer; paclitaxel; pharmacokinetics; biomarkers; metastatic breast cancer; mBC; TNBC
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Paclitaxel

Study Results

Participant Flow

Recruitment Details	Participants who met all the inclusion and none of the exclusion criteria were enrolled
Pre-assignment Detail	All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. The study was terminated prior to completing enrollment, hence descriptive statistical analyses were performed for a limited set of data.

Arm/Group Title	Placebo in Combination With Paclitaxel	Tivozanib Hydrochloride in Combination With Paclitaxel
Arm/Group Description	Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.	Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
Period Title: Overall Study
STARTED	8	22
Treated	8	21
COMPLETED	0	0
NOT COMPLETED	8	22

Baseline Characteristics

Arm/Group Title	Placebo in Combination With Paclitaxel	Tivozanib Hydrochloride in Combination With Paclitaxel	Total
Arm/Group Description	Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.	Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.	Total of all reporting groups
Overall Participants	8	22	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 50%	20 90.9%	24 80%
>=65 years	4 50%	2 9.1%	6 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (16.02)	54.5 (10.06)	56.3 (12.02)
Sex: Female, Male (Count of Participants)
Female	8 100%	22 100%	30 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	8 100%	14 63.6%	22 73.3%
Black	0 0%	5 22.7%	5 16.7%
Asian	0 0%	2 9.1%	2 6.7%
Dominican	0 0%	1 4.5%	1 3.3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.6 (10.67)	182.3 (708.53)	144.4 (613.48)

Outcome Measures

1. Primary Outcome

Title	Comparison of Progression-free Survival (PFS) of Subjects
Description	PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

2. Secondary Outcome

Title	Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects
Description	ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

3. Secondary Outcome

Title	Comparison of Overall Survival (OS) of Subjects
Description	OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

4. Secondary Outcome

Title	Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel
Description	Number of subjects with serious and non-serious adverse events.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events).

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	21	8
Subjects with serious adverse events	1 12.5%	1 4.5%
Subjects with non-serious adverse events	19 237.5%	8 36.4%

5. Secondary Outcome

Title	Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination
Description	PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

6. Secondary Outcome

Title	Identification of Hypoxia Gene Signature
Description	Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.
Time Frame	Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

7. Secondary Outcome

Title	Measurement of Subjects' Quality of Life (QoL)
Description	The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Arm/Group Title	Tivozanib Hydrochloride in Combination With Paclitaxel	Placebo in Combination With Paclitaxel
Arm/Group Description	1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.	Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
Measure Participants	0	0

Adverse Events

Time Frame	14 months
Adverse Event Reporting Description	Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
Arm/Group Title	Placebo in Combination With Paclitaxel		Tivozanib Hydrochloride in Combination With Paclitaxel
Arm/Group Description	Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.		Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
All Cause Mortality
	Placebo in Combination With Paclitaxel		Tivozanib Hydrochloride in Combination With Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo in Combination With Paclitaxel		Tivozanib Hydrochloride in Combination With Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		1/21 (4.8%)
Gastrointestinal disorders
Diarrhoea	0/8 (0%)	0	1/21 (4.8%)	1
Nausea	0/8 (0%)	0	1/21 (4.8%)	1
General disorders
Fatigue	0/8 (0%)	0	1/21 (4.8%)	1
Metabolism and nutrition disorders
Dehydration	0/8 (0%)	0	1/21 (4.8%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic	1/8 (12.5%)	1	0/21 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/8 (12.5%)	1	0/21 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo in Combination With Paclitaxel		Tivozanib Hydrochloride in Combination With Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/8 (100%)		19/21 (90.5%)
Blood and lymphatic system disorders
Anaemia	3/8 (37.5%)		5/21 (23.8%)
Neutropenia	2/8 (25%)		8/21 (38.1%)
Leukopenia	0/8 (0%)		3/21 (14.3%)
Thrombocytopenia	0/8 (0%)		2/21 (9.5%)
Ear and labyrinth disorders
Vertigo	1/8 (12.5%)		0/21 (0%)
Endocrine disorders
Endocrine disorders	0/8 (0%)		3/21 (14.3%)
Eye disorders
Ocular hyperaemia	1/8 (12.5%)		0/21 (0%)
Gastrointestinal disorders
Nausea	4/8 (50%)		9/21 (42.9%)
Constipation	3/8 (37.5%)		6/21 (28.6%)
Abdominal distension	1/8 (12.5%)		0/21 (0%)
Abdominal pain	1/8 (12.5%)		2/21 (9.5%)
Abdominal pain upper	1/8 (12.5%)		0/21 (0%)
Dyspepsia	1/8 (12.5%)		0/21 (0%)
Dysphagia	1/8 (12.5%)		0/21 (0%)
Stomatitis	1/8 (12.5%)		6/21 (28.6%)
Vomiting	1/8 (12.5%)		5/21 (23.8%)
Gastrooesophageal reflux disease	0/8 (0%)		3/21 (14.3%)
Oral pain	0/8 (0%)		2/21 (9.5%)
General disorders
Faitgue	4/8 (50%)		11/21 (52.4%)
Oedema peripheral	2/8 (25%)		0/21 (0%)
Asthenia	1/8 (12.5%)		0/21 (0%)
Infections and infestations
Bronchitis	1/8 (12.5%)		0/21 (0%)
Urinary tract infection	2/8 (25%)		3/21 (14.3%)
Rash pustular	1/8 (12.5%)		0/21 (0%)
Sinusitis	1/8 (12.5%)		0/21 (0%)
Upper respiratory tract infection	1/8 (12.5%)		0/21 (0%)
Folliculitis	0/8 (0%)		2/21 (9.5%)
Injury, poisoning and procedural complications
Fall	1/8 (12.5%)		0/21 (0%)
Laceration	1/8 (12.5%)		0/21 (0%)
Infusion related reaction	0/8 (0%)		2/21 (9.5%)
Investigations
Blood lactate dehydrogenase increased	1/8 (12.5%)		0/21 (0%)
Liver function test abnormal	1/8 (12.5%)		0/21 (0%)
Neutrophil count decreased	1/8 (12.5%)		3/21 (14.3%)
Platelet count increased	1/8 (12.5%)		0/21 (0%)
Alanine aminotransferase increased	0/8 (0%)		2/21 (9.5%)
Blood thyroid stimulating hormone increased	0/8 (0%)		3/21 (14.3%)
Lipase increased	0/8 (0%)		2/21 (9.5%)
Metabolism and nutrition disorders
Decreased appetite	1/8 (12.5%)		5/21 (23.8%)
Hypokalaemia	1/8 (12.5%)		2/21 (9.5%)
Hypomagnesaemia	0/8 (0%)		2/21 (9.5%)
Hyponatraemia	0/8 (0%)		2/21 (9.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/8 (25%)		3/21 (14.3%)
Back Pain	1/8 (12.5%)		0/21 (0%)
Muscular weakness	1/8 (12.5%)		0/21 (0%)
Myalgia	1/8 (12.5%)		3/21 (14.3%)
Pain in extremity	1/8 (12.5%)		0/21 (0%)
Bone pain	0/8 (0%)		2/21 (9.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic	1/8 (12.5%)		0/21 (0%)
Metastasis	0/8 (0%)		2/21 (9.5%)
Nervous system disorders
Peripheral sensory neuropathy	2/8 (25%)		4/21 (19%)
Dysgeusia	1/8 (12.5%)		3/21 (14.3%)
Headache	1/8 (12.5%)		4/21 (19%)
Neuropathy peripheral	1/8 (12.5%)		5/21 (23.8%)
Presyncope	1/8 (12.5%)		0/21 (0%)
Dizziness	0/8 (0%)		2/21 (9.5%)
Hypoaesthesia	0/8 (0%)		3/21 (14.3%)
Paraesthesia	0/8 (0%)		2/21 (9.5%)
Psychiatric disorders
Insomnia	0/8 (0%)		2/21 (9.5%)
Renal and urinary disorders
Haematuria	1/8 (12.5%)		0/21 (0%)
Dysuria	0/8 (0%)		2/21 (9.5%)
Reproductive system and breast disorders
Pelvic pain	1/8 (12.5%)		0/21 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/8 (12.5%)		3/21 (14.3%)
Epistaxis	1/8 (12.5%)		2/21 (9.5%)
Rhinitis allergic	1/8 (12.5%)		0/21 (0%)
Upper-airway cough syndrome	1/8 (12.5%)		0/21 (0%)
Cough	0/8 (0%)		9/21 (42.9%)
Oropharyngeal pain	0/8 (0%)		3/21 (14.3%)
Skin and subcutaneous tissue disorders
Alopecia	4/8 (50%)		7/21 (33.3%)
Pruritis	1/8 (12.5%)		0/21 (0%)
Pruritis Genralized	1/8 (12.5%)		0/21 (0%)
Rash	1/8 (12.5%)		4/21 (19%)
Palmar-plantar erythrodysaesthesia syndrome	0/8 (0%)		2/21 (9.5%)
Vascular disorders
Poor venous access	1/8 (12.5%)		0/21 (0%)
Hypertension	0/8 (0%)		7/21 (33.3%)

Limitations/Caveats

The Sponsor terminated Study AV-951-12-204 before enrollment was completed after determining that enrollment of subjects was much lower than expected, and that timely completion of the study was not feasible.

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.