OVERT-1: AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00610714
• Collaborator: (none)
• Enrollment: 211
• Locations: 50
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms; Ovarian Cancer	Drug: AZD0530; Drug: Carboplatin; Drug: Paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Comparator carboplatin plus paclitaxel	Drug: Carboplatin; intravenous injection; Other Names: CBDCA Paraplatin® ; Drug: Paclitaxel; intravenous infusion; Other Names: Taxol®
Experimental: 2 AZD0530 in combination with carboplatin plus paclitaxel	Drug: AZD0530; oral once daily dose; Drug: Carboplatin; intravenous injection; Other Names: CBDCA Paraplatin® ; Drug: Paclitaxel; intravenous infusion; Other Names: Taxol®

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) [Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)]

   Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.

Secondary Outcome Measures

1. Progression-free Survival (PFS) as Evaluated by RECIST [Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)]

   Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.

2. Overall Survival (Number of Deaths) [Date of randomization to death due to any cause]

   Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have a diagnosis of advanced ovarian cancer

• Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy

• Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

• Central Nervous System (CNS) metastases

• Received more than 2 prior chemotherapy regimens for ovarian cancer treatment

• Inadequate bone marrow reserve

• Inadequate liver function, renal function or low haemoglobin

• Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Pleven		Bulgaria
2	Research Site	Plovdiv		Bulgaria
3	Research Site	Sofia		Bulgaria
4	Research Site	Varna		Bulgaria
5	Research Site	Edmonton	Alberta	Canada
6	Research Site	Vancouver	British Columbia	Canada
7	Research Site	St. John's	Newfoundland and Labrador	Canada
8	Research Site	Ottawa	Ontario	Canada
9	Research Site	Toronto	Ontario	Canada
10	Research Site	Montreal	Quebec	Canada
11	Research Site	Sherbrooke	Quebec	Canada
12	Research Site	Quebec		Canada
13	Research Site	Alborg		Denmark
14	Research Site	Herning		Denmark
15	Research Site	Naestved		Denmark
16	Research Site	Paris	Cedex 04	France
17	Research Site	Avignon		France
18	Research Site	Bordeaux Cedex		France
19	Research Site	Caen Cedex		France
20	Research Site	Lyon Cedex 08		France
21	Research Site	Montpellier Cedex 5		France
22	Research Site	Nantes		France
23	Research Site	Pierre Benite Cedex		France
24	Research Site	Reims Cedex		France
25	Research Site	Vandoeuvre Les Nancy		France
26	Research Site	Amsterdam		Netherlands
27	Research Site	Den Haag		Netherlands
28	Research Site	Leiden		Netherlands
29	Research Site	Nijmegen		Netherlands
30	Research Site	Bergen		Norway
31	Research Site	Oslo		Norway
32	Research Site	Lima		Peru
33	Research Site	Coimbra		Portugal
34	Research Site	Funchal		Portugal
35	Research Site	Lisboa		Portugal
36	Research Site	Porto		Portugal
37	Research Site	Baia Mare	Maramures	Romania
38	Research Site	Alba Iulia		Romania
39	Research Site	Bucharest		Romania
40	Research Site	Cluj Napoca		Romania
41	Research Site	Kazan		Russian Federation
42	Research Site	Moscow		Russian Federation
43	Research Site	Nizhniy Novgorod		Russian Federation
44	Research Site	St. Petersburg		Russian Federation
45	Research Site	Cordoba	Andalucia	Spain
46	Research Site	Barcelona	Cataluna	Spain
47	Research Site	Hospitalet Dellobregat(barcelo	Cataluna	Spain
48	Research Site	Madrid	Comunidad de Madrid	Spain
49	Research Site	Valencia	Comunidad Valenciana	Spain
50	Research Site	Coventry		United Kingdom

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Chris Poole, Prof, Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
• Study Director: Mireille Cantarini, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00610714
• Other Study ID Numbers: D8180C00015; AZD0530 Study 15
• First Posted: Feb 8, 2008
• Last Update Posted: Dec 18, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by AstraZeneca: Cancer; Tumour; Ovarian Neoplasms; Ovarian Cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Paclitaxel; Carboplatin; Saracatinib

Study Results

Participant Flow

Recruitment Details	Patients were recruited at 58 cancer clinics in 12 countries (Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russia, Spain and UK) between April 2008 and March 2009.
Pre-assignment Detail	Following enrolment there was a 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.	Carboplatin ,Paclitaxel
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level	Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
Period Title: Overall Study
STARTED	105	106
COMPLETED	79	82
NOT COMPLETED	26	24

Baseline Characteristics

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.	Carboplatin ,Paclitaxel	Total
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level	Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;	Total of all reporting groups
Overall Participants	105	106	211
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.4 (9.9)	59.1 (10.2)	58.265 (10.077)
Sex/Gender, Customized (Number) [Number]
Female	105 100%	106 100%	211 100%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	94 89.5%	99 93.4%	193 91.5%
Black	1 1%	0 0%	1 0.5%
Asian	2 1.9%	3 2.8%	5 2.4%
Other	8 7.6%	4 3.8%	12 5.7%
Body Surface Area (BSA) (m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m^2]	1.758 (0.17)	1.766 (0.206)	1.762 (0.189)
World Health Organization (WHO) Performance Status (Number) [Number]
0	60 57.1%	63 59.4%	123 58.3%
1	41 39%	42 39.6%	83 39.3%
2	4 3.8%	1 0.9%	5 2.4%
3	0 0%	0 0%	0 0%
4	0 0%	0 0%	0 0%
Primary Tumour Location (Number of Participants) (Number) [Number]
Ovary	98 93.3%	98 92.5%	196 92.9%
Peritoneum	4 3.8%	5 4.7%	9 4.3%
Uterine/fallopian tube	3 2.9%	1 0.9%	4 1.9%
Site cannot be determined	0 0%	1 0.9%	1 0.5%
Unavailable	0 0%	1 0.9%	1 0.5%
Tumour Grade (Number) [Number]
Well Differentiated (G1)	8 7.6%	8 7.5%	16 7.6%
Mod. Differentiated (G2)	29 27.6%	25 23.6%	54 25.6%
Unavailable (G3)	45 42.9%	53 50%	98 46.4%
Undifferentiated (G4)	4 3.8%	6 5.7%	10 4.7%
Unassessable (GX)	15 14.3%	14 13.2%	29 13.7%
Missing	4 3.8%	0 0%	4 1.9%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Description	Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.
Time Frame	Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.	Carboplatin ,Paclitaxel
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level	Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
Measure Participants	88	87
Number [Participants]	47 44.8%	45 42.5%

2. Secondary Outcome

Title	Progression-free Survival (PFS) as Evaluated by RECIST
Description	Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.
Time Frame	Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.	Carboplatin ,Paclitaxel
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level	Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
Measure Participants	96	93
Median (Full Range) [Months]	8.28	7.79

3. Secondary Outcome

Title	Overall Survival (Number of Deaths)
Description	Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead
Time Frame	Date of randomization to death due to any cause

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.	Carboplatin ,Paclitaxel
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level	Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
Measure Participants	96	93
Number [Participants]	12 11.4%	14 13.2%

Adverse Events

Arm/Group Title	AZD0530 , Paclitaxel , Carboplatin i.v.		Carboplatin ,Paclitaxel
Arm/Group Description	AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level		Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
All Cause Mortality
	AZD0530 , Paclitaxel , Carboplatin i.v.		Carboplatin ,Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AZD0530 , Paclitaxel , Carboplatin i.v.		Carboplatin ,Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/105 (43.8%)		26/106 (24.5%)
Blood and lymphatic system disorders
Febrile Neutropenia	14/105 (13.3%)		2/106 (1.9%)
Anaemia	3/105 (2.9%)		0/106 (0%)
Thrombocytopenia	3/105 (2.9%)		0/106 (0%)
Neutropenia	1/105 (1%)		2/106 (1.9%)
Febrile Bone Marrow Aplasia	1/105 (1%)		1/106 (0.9%)
Pancytopenia	0/105 (0%)		1/106 (0.9%)
Cardiac disorders
Atrial Fibrillation	2/105 (1.9%)		0/106 (0%)
Pericardial Effusion	0/105 (0%)		1/106 (0.9%)
Gastrointestinal disorders
Ileus	3/105 (2.9%)		0/106 (0%)
Vomiting	3/105 (2.9%)		1/106 (0.9%)
Ascites	1/105 (1%)		2/106 (1.9%)
Intestinal Obstruction	2/105 (1.9%)		0/106 (0%)
Abdominal Hernia	0/105 (0%)		1/106 (0.9%)
Abdominal Pain	1/105 (1%)		0/106 (0%)
Constipation	1/105 (1%)		0/106 (0%)
Diarrhoea	1/105 (1%)		1/106 (0.9%)
Faeces Discoloured	1/105 (1%)		0/106 (0%)
Gastrointestinal Haemorrhage	1/105 (1%)		0/106 (0%)
Intestinal Fistula	1/105 (1%)		0/106 (0%)
Lower Gastrointestinal Haemorrhage	1/105 (1%)		0/106 (0%)
Nausea	1/105 (1%)		0/106 (0%)
Subileus	0/105 (0%)		1/106 (0.9%)
Umbilical Hernia	0/105 (0%)		1/106 (0.9%)
General disorders
Pyrexia	4/105 (3.8%)		1/106 (0.9%)
Asthenia	2/105 (1.9%)		0/106 (0%)
Immune system disorders
Drug Hypersensitivity	4/105 (3.8%)		5/106 (4.7%)
Anaphylactic Shock	0/105 (0%)		1/106 (0.9%)
Infections and infestations
Abdominal Infection	0/105 (0%)		1/106 (0.9%)
Abdominal Wall Abscess	1/105 (1%)		0/106 (0%)
Cellulitis	1/105 (1%)		0/106 (0%)
Device Related Infection	0/105 (0%)		1/106 (0.9%)
Device Related Sepsis	1/105 (1%)		0/106 (0%)
Enteritis Infectious	1/105 (1%)		0/106 (0%)
Escherichia Infection	1/105 (1%)		0/106 (0%)
Neutropenic Infection	1/105 (1%)		0/106 (0%)
Septic Shock	0/105 (0%)		1/106 (0.9%)
Staphylococcal Bacteraemia	0/105 (0%)		1/106 (0.9%)
Upper Respiratory Tract Infection	0/105 (0%)		1/106 (0.9%)
Urosepsis	1/105 (1%)		0/106 (0%)
Injury, poisoning and procedural complications
Operative Haemorrhage	0/105 (0%)		1/106 (0.9%)
Tibia Fracture	0/105 (0%)		1/106 (0.9%)
Aspartate Aminotransferase Increased	1/105 (1%)		0/106 (0%)
Blood Creatinine Increased	1/105 (1%)		0/106 (0%)
Haemoglobin Decreased	0/105 (0%)		1/106 (0.9%)
Metabolism and nutrition disorders
Dehydration	0/105 (0%)		2/106 (1.9%)
Decreased Appetite	1/105 (1%)		0/106 (0%)
Hypokalaemia	1/105 (1%)		0/106 (0%)
Hyponatraemia	1/105 (1%)		0/106 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome	1/105 (1%)		0/106 (0%)
Nervous system disorders
Cerebral Haemorrhage	0/105 (0%)		1/106 (0.9%)
Presyncope	0/105 (0%)		1/106 (0.9%)
Somnolence	0/105 (0%)		1/106 (0.9%)
Renal and urinary disorders
Renal Colic	1/105 (1%)		0/106 (0%)
Renal Failure Acute	1/105 (1%)		0/106 (0%)
Reproductive system and breast disorders
Female Genital Tract Fistula	0/105 (0%)		1/106 (0.9%)
Vaginal Haemorrhage	1/105 (1%)		0/106 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema	1/105 (1%)		0/106 (0%)
Acute Respiratory Distress Syndrome	1/105 (1%)		0/106 (0%)
Dyspnoea	1/105 (1%)		0/106 (0%)
Lung Disorder	1/105 (1%)		0/106 (0%)
Pneumonitis	1/105 (1%)		0/106 (0%)
Pulmonary Embolism	1/105 (1%)		1/106 (0.9%)
Vascular disorders
Hot Flush	0/105 (0%)		1/106 (0.9%)
Other (Not Including Serious) Adverse Events
	AZD0530 , Paclitaxel , Carboplatin i.v.		Carboplatin ,Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	102/105 (97.1%)		104/106 (98.1%)
Blood and lymphatic system disorders
Neutropenia	45/105 (42.9%)		38/106 (35.8%)
Anaemia	40/105 (38.1%)		34/106 (32.1%)
Thrombocytopenia	28/105 (26.7%)		31/106 (29.2%)
Leukopenia	17/105 (16.2%)		8/106 (7.5%)
Febrile Neutropenia	7/105 (6.7%)		0/106 (0%)
Gastrointestinal disorders
Nausea	68/105 (64.8%)		64/106 (60.4%)
Diarrhoea	44/105 (41.9%)		36/106 (34%)
Vomiting	43/105 (41%)		39/106 (36.8%)
Constipation	27/105 (25.7%)		30/106 (28.3%)
Abdominal Pain	15/105 (14.3%)		22/106 (20.8%)
Abdominal Pain Upper	13/105 (12.4%)		10/106 (9.4%)
Stomatitis	6/105 (5.7%)		10/106 (9.4%)
General disorders
Fatigue	37/105 (35.2%)		42/106 (39.6%)
Asthenia	36/105 (34.3%)		30/106 (28.3%)
Pyrexia	22/105 (21%)		11/106 (10.4%)
Oedema Peripheral	3/105 (2.9%)		9/106 (8.5%)
Mucosal Inflammation	6/105 (5.7%)		7/106 (6.6%)
Malaise	3/105 (2.9%)		6/106 (5.7%)
Immune system disorders
Drug Hypersensitivity	16/105 (15.2%)		24/106 (22.6%)
Infections and infestations
Nasopharyngitis	8/105 (7.6%)		15/106 (14.2%)
Urinary Tract Infection	11/105 (10.5%)		9/106 (8.5%)
Cystitis	8/105 (7.6%)		2/106 (1.9%)
Weight Decreased	6/105 (5.7%)		5/106 (4.7%)
Metabolism and nutrition disorders
Decreased Appetite	33/105 (31.4%)		22/106 (20.8%)
Hypokalaemia	11/105 (10.5%)		2/106 (1.9%)
Hypocalcaemia	8/105 (7.6%)		1/106 (0.9%)
Hypomagnesaemia	3/105 (2.9%)		6/106 (5.7%)
Musculoskeletal and connective tissue disorders
Myalgia	16/105 (15.2%)		26/106 (24.5%)
Arthralgia	19/105 (18.1%)		25/106 (23.6%)
Back Pain	5/105 (4.8%)		13/106 (12.3%)
Bone Pain	0/105 (0%)		9/106 (8.5%)
Pain In Extremity	5/105 (4.8%)		9/106 (8.5%)
Musculoskeletal Pain	6/105 (5.7%)		8/106 (7.5%)
Nervous system disorders
Peripheral Sensory Neuropathy	28/105 (26.7%)		26/106 (24.5%)
Neuropathy Peripheral	17/105 (16.2%)		24/106 (22.6%)
Headache	9/105 (8.6%)		14/106 (13.2%)
Paraesthesia	8/105 (7.6%)		14/106 (13.2%)
Dizziness	5/105 (4.8%)		11/106 (10.4%)
Dysgeusia	8/105 (7.6%)		6/106 (5.7%)
Psychiatric disorders
Anxiety	1/105 (1%)		15/106 (14.2%)
Insomnia	6/105 (5.7%)		9/106 (8.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	9/105 (8.6%)		19/106 (17.9%)
Cough	11/105 (10.5%)		17/106 (16%)
Epistaxis	9/105 (8.6%)		6/106 (5.7%)
Skin and subcutaneous tissue disorders
Alopecia	55/105 (52.4%)		64/106 (60.4%)
Rash	15/105 (14.3%)		13/106 (12.3%)
Pruritus	3/105 (2.9%)		9/106 (8.5%)
Erythema	7/105 (6.7%)		3/106 (2.8%)
Vascular disorders
Hypertension	3/105 (2.9%)		6/106 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.