Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) (SUMIT)

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ClinicalTrials.gov Identifier: NCT01974752

Recruitment Status : Completed

First Posted : November 3, 2013

Results First Posted : September 28, 2016

Last Update Posted : January 5, 2017

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Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Metastatic Uveal Melanoma
Interventions	Drug: 75mg selumetinib Drug: placebo Drug: Dacarbazine
Enrollment	152

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description	Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Period Title: Overall Study
Started	97	32
Completed	60	17
Not Completed	37	15
Reason Not Completed
Death	33	11
Lost to Follow-up	2	0
Withdrawal by Subject	2	3
Other Eligibility Criteria	0	1

Baseline Characteristics

Arm/Group Title		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2	Total
Arm/Group Description		Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2	Total of all reporting groups
Arm/Group Description		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2	Total of all reporting groups
Overall Number of Baseline Participants		97	32	129
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	97 participants	32 participants	129 participants
		61.0 (12.28)	59.6 (11.28)	60.6 (12.01)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	97 participants	32 participants	129 participants
<55 years		26	11	37
>=55 years To <65 years		25	9	34
>=65 years		46	12	58
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	97 participants	32 participants	129 participants
	Female	42 43.3%	19 59.4%	61 47.3%
	Male	55 56.7%	13 40.6%	68 52.7%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	97 participants	32 participants	129 participants
Other		1	1	2
White		96	31	127

Outcome Measures

1.Primary Outcome


Title	Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.
Description	Progression free survival (PFS) using blinded independent central revi...
Description	Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015

Outcome Measure Data

Analysis Population Description

All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).


Arm/Group Title	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Overall Number of Participants Analyzed	97	32
Measure Type: Number Unit of Measure: number of progression events
	82	24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2, Placebo + Dacarbazine 1000 mg/m2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3195
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Factor for treatment and liver metastases

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95% 0.48 to 1.27
	Estimation Comments	A hazard ratio < 1 favours Selumetinib in combination with Dacarbazine

2.Secondary Outcome


Title	Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR
Description	ORR at Week 6 using BICR according to RECIST 1.1
Description	ORR at Week 6 using BICR according to RECIST 1.1
Time Frame	From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015

Outcome Measure Data

Analysis Population Description

Full Analysis Set


Arm/Group Title	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Overall Number of Participants Analyzed	97	32
Measure Type: Number Unit of Measure: number of responders
	3	0

3.Secondary Outcome


Title	Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR
Description	Percent change in tumour size at Week 6 using BICR according to RECIST...
Description	Percent change in tumour size at Week 6 using BICR according to RECIST 1.1
Time Frame	From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Overall Number of Participants Analyzed	92	27
Mean (Standard Deviation) Unit of Measure: percent change
	6.94 (18.001)	19.76 (38.264)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2, Placebo + Dacarbazine 1000 mg/m2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1284
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.

Method of Estimation	Estimation Parameter	Geometric LS mean ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95% 0.88 to 1.02
	Estimation Comments	A geometric least squares mean ratio < 1 favours Selumetinib in combination with Dacarbazine

4.Secondary Outcome


Title	Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine
Description	Overall Survival
Description	Overall Survival
Time Frame	From Randomization, up until death assessed up to 15th May 2015

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine ...	Placebo + Dacarbazine 1000 mg/m2
Arm/Group Description:	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2	Placebo + Dacarbazine 1000 mg/m2
Overall Number of Participants Analyzed	97	32
Measure Type: Number Unit of Measure: Number of Overall Survival Events
	34	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2, Placebo + Dacarbazine 1000 mg/m2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4011
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95% 0.39 to 1.46
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From informed consent up until end of double blind period
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
Arm/Group Description	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine ...
Arm/Group Description	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
All-Cause Mortality
	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.25%)		20/97 (20.62%)
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
FEBRILE NEUTROPENIA ^† 1	1/32 (3.13%)	1	1/97 (1.03%)	1
PANCYTOPENIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
THROMBOCYTOPENIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Cardiac disorders
ATRIAL FLUTTER ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
CARDIAC FAILURE ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
PERICARDIAL EFFUSION ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Eye disorders
RETINAL VEIN OCCLUSION ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Gastrointestinal disorders
CONSTIPATION ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	2
DIARRHOEA ^† 1	1/32 (3.13%)	1	0/97 (0.00%)	0
VOMITING ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
General disorders
ASTHENIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
CHEST PAIN ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
PYREXIA ^† 1	0/32 (0.00%)	0	2/97 (2.06%)	2
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Immune system disorders
DRUG HYPERSENSITIVITY ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Infections and infestations
PNEUMONIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
DEVICE RELATED SEPSIS ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
STREPTOCOCCAL BACTERAEMIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
URINARY TRACT INFECTION ^† 1	1/32 (3.13%)	1	2/97 (2.06%)	2
Injury, poisoning and procedural complications
FALL ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
HIP FRACTURE ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Investigations
BLOOD BILIRUBIN INCREASED ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
BLOOD CREATININE INCREASED ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
TRANSAMINASES INCREASED ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Musculoskeletal and connective tissue disorders
NECK PAIN ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Renal and urinary disorders
HAEMATURIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
PULMONARY EMBOLISM ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Skin and subcutaneous tissue disorders
URTICARIA ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
Vascular disorders
HYPOTENSION ^† 1	0/32 (0.00%)	0	1/97 (1.03%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 17.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo + Dacarbazine 1000 mg/m2		Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/32 (100.00%)		97/97 (100.00%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	4/32 (12.50%)	6	18/97 (18.56%)	22
NEUTROPENIA ^† 1	11/32 (34.38%)	14	25/97 (25.77%)	35
THROMBOCYTOPENIA ^† 1	4/32 (12.50%)	4	26/97 (26.80%)	39
LEUKOPENIA ^† 1	3/32 (9.38%)	3	0/97 (0.00%)	0
Eye disorders
VISION BLURRED ^† 1	1/32 (3.13%)	1	10/97 (10.31%)	11
Gastrointestinal disorders
CONSTIPATION ^† 1	14/32 (43.75%)	19	37/97 (38.14%)	46
ABDOMINAL PAIN ^† 1	3/32 (9.38%)	3	11/97 (11.34%)	12
ABDOMINAL PAIN UPPER ^† 1	3/32 (9.38%)	4	8/97 (8.25%)	8
DIARRHOEA ^† 1	7/32 (21.88%)	11	43/97 (44.33%)	83
DRY MOUTH ^† 1	2/32 (6.25%)	2	9/97 (9.28%)	9
DYSPEPSIA ^† 1	2/32 (6.25%)	2	11/97 (11.34%)	12
GASTROINTESTINAL PAIN ^† 1	2/32 (6.25%)	2	0/97 (0.00%)	0
GASTROOESOPHAGEAL REFLUX DISEASE ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	5
NAUSEA ^† 1	6/32 (18.75%)	12	60/97 (61.86%)	92
STOMATITIS ^† 1	2/32 (6.25%)	2	15/97 (15.46%)	16
VOMITING ^† 1	6/32 (18.75%)	7	27/97 (27.84%)	36
General disorders
ASTHENIA ^† 1	4/32 (12.50%)	5	20/97 (20.62%)	21
CHILLS ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	6
FACE OEDEMA ^† 1	0/32 (0.00%)	0	6/97 (6.19%)	7
FATIGUE ^† 1	15/32 (46.88%)	16	43/97 (44.33%)	49
OEDEMA PERIPHERAL ^† 1	2/32 (6.25%)	2	42/97 (43.30%)	47
PYREXIA ^† 1	5/32 (15.63%)	6	8/97 (8.25%)	9
Hepatobiliary disorders
HEPATIC PAIN ^† 1	3/32 (9.38%)	3	3/97 (3.09%)	3
Infections and infestations
BRONCHITIS ^† 1	0/32 (0.00%)	0	5/97 (5.15%)	5
LOWER RESPIRATORY TRACT INFECTION ^† 1	2/32 (6.25%)	2	0/97 (0.00%)	0
NASOPHARYNGITIS ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	6
URINARY TRACT INFECTION ^† 1	3/32 (9.38%)	3	9/97 (9.28%)	9
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED ^† 1	2/32 (6.25%)	3	6/97 (6.19%)	6
ALANINE AMINOTRANSFERASE INCREASED ^† 1	5/32 (15.63%)	7	28/97 (28.87%)	36
ASPARTATE AMINOTRANSFERASE INCREASED ^† 1	5/32 (15.63%)	8	29/97 (29.90%)	36
BLOOD ALKALINE PHOSPHATASE INCREASED ^† 1	2/32 (6.25%)	3	8/97 (8.25%)	8
BLOOD CREATINE PHOSPHOKINASE INCREASED ^† 1	2/32 (6.25%)	2	36/97 (37.11%)	40
NEUTROPHIL COUNT DECREASED ^† 1	1/32 (3.13%)	1	6/97 (6.19%)	8
PLATELET COUNT DECREASED ^† 1	3/32 (9.38%)	4	7/97 (7.22%)	10
WEIGHT DECREASED ^† 1	2/32 (6.25%)	2	1/97 (1.03%)	1
Metabolism and nutrition disorders
HYPERGLYCAEMIA ^† 1	2/32 (6.25%)	4	4/97 (4.12%)	5
DECREASED APPETITE ^† 1	9/32 (28.13%)	9	17/97 (17.53%)	18
HYPERKALAEMIA ^† 1	2/32 (6.25%)	3	5/97 (5.15%)	6
HYPOALBUMINAEMIA ^† 1	2/32 (6.25%)	2	6/97 (6.19%)	8
HYPONATRAEMIA ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	6
Musculoskeletal and connective tissue disorders
NECK PAIN ^† 1	0/32 (0.00%)	0	5/97 (5.15%)	5
PAIN IN EXTREMITY ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	5
ARTHRALGIA ^† 1	4/32 (12.50%)	6	5/97 (5.15%)	6
BACK PAIN ^† 1	0/32 (0.00%)	0	9/97 (9.28%)	10
MUSCULOSKELETAL CHEST PAIN ^† 1	3/32 (9.38%)	4	1/97 (1.03%)	1
MUSCULOSKELETAL PAIN ^† 1	3/32 (9.38%)	3	4/97 (4.12%)	4
MYALGIA ^† 1	1/32 (3.13%)	1	12/97 (12.37%)	14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN ^† 1	2/32 (6.25%)	2	2/97 (2.06%)	3
Nervous system disorders
PARAESTHESIA ^† 1	2/32 (6.25%)	4	5/97 (5.15%)	5
DIZZINESS ^† 1	3/32 (9.38%)	3	6/97 (6.19%)	7
DYSGEUSIA ^† 1	3/32 (9.38%)	4	11/97 (11.34%)	11
HEADACHE ^† 1	3/32 (9.38%)	3	13/97 (13.40%)	13
SYNCOPE ^† 1	0/32 (0.00%)	0	6/97 (6.19%)	7
Psychiatric disorders
INSOMNIA ^† 1	4/32 (12.50%)	4	8/97 (8.25%)	8
Respiratory, thoracic and mediastinal disorders
DYSPNOEA ^† 1	3/32 (9.38%)	3	19/97 (19.59%)	23
OROPHARYNGEAL PAIN ^† 1	2/32 (6.25%)	2	4/97 (4.12%)	4
COUGH ^† 1	1/32 (3.13%)	1	9/97 (9.28%)	9
EPISTAXIS ^† 1	1/32 (3.13%)	1	5/97 (5.15%)	6
Skin and subcutaneous tissue disorders
DRY SKIN ^† 1	0/32 (0.00%)	0	11/97 (11.34%)	12
ALOPECIA ^† 1	1/32 (3.13%)	1	6/97 (6.19%)	6
DERMATITIS ACNEIFORM ^† 1	1/32 (3.13%)	1	30/97 (30.93%)	37
HYPERHIDROSIS ^† 1	3/32 (9.38%)	3	3/97 (3.09%)	3
PHOTOSENSITIVITY REACTION ^† 1	2/32 (6.25%)	2	0/97 (0.00%)	0
PRURITUS ^† 1	4/32 (12.50%)	5	14/97 (14.43%)	15
RASH ^† 1	2/32 (6.25%)	2	55/97 (56.70%)	60
SKIN FISSURES ^† 1	0/32 (0.00%)	0	12/97 (12.37%)	14
Vascular disorders
HYPERTENSION ^† 1	2/32 (6.25%)	2	19/97 (19.59%)	19
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 17.1

Limitations and 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Karin Bowen
Organization:	AstraZeneca
Phone:	+001 301 398 3254
EMail:	karin.bowen@astrazeneca.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carvajal RD, Piperno-Neumann S, Kapiteijn E, Chapman PB, Frank S, Joshua AM, Piulats JM, Wolter P, Cocquyt V, Chmielowski B, Evans TRJ, Gastaud L, Linette G, Berking C, Schachter J, Rodrigues MJ, Shoushtari AN, Clemett D, Ghiorghiu D, Mariani G, Spratt S, Lovick S, Barker P, Kilgour E, Lai Z, Schwartz GK, Nathan P. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT). J Clin Oncol. 2018 Apr 20;36(12):1232-1239. doi: 10.1200/JCO.2017.74.1090. Epub 2018 Mar 12. Erratum In: J Clin Oncol. 2018 Dec 10;36(35):3528.

Carvajal RD, Schwartz GK, Mann H, Smith I, Nathan PD. Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT). BMC Cancer. 2015 Jun 10;15:467. doi: 10.1186/s12885-015-1470-z.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01974752
Other Study ID Numbers:	D1344C00001
First Submitted:	October 10, 2013
First Posted:	November 3, 2013
Results First Submitted:	May 9, 2016
Results First Posted:	September 28, 2016
Last Update Posted:	January 5, 2017

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