AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

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ClinicalTrials.gov Identifier: NCT00890825

Recruitment Status : Completed

First Posted : April 30, 2009

Results First Posted : June 20, 2018

Last Update Posted : June 20, 2018

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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
Condition	Non Small Cell Lung Cancer
Interventions	Drug: AZD6244 Drug: docetaxel Drug: Placebo
Enrollment	88

Participant Flow

Recruitment Details	Selection of patients was in 2nd line patients with KRAS mutation positive locally advanced or metastatic NSCLC (Stage IIIB - IV).First patient enrolled: 20 April 2009.Last patient last visit: 30 June 2010.Data Cut Off (DCO): 01 May 2011
Pre-assignment Details


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Period Title: Overall Study
Started	44	43 ^[1]
Completed	30	29
Not Completed	14	14
Reason Not Completed
Withdrawal by Subject	1	0
Alive at data cut off (DCO)	13	14
[1] A patient randomized to this arm was excluded from the safety population for not receiving treatment

Baseline Characteristics

Arm/Group Title		AZD6244 + Docetaxel	Placebo + Docetaxel	Total
Arm/Group Description		AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2	Total of all reporting groups
Arm/Group Description		AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2	Total of all reporting groups
Overall Number of Baseline Participants		44	43	87
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Intention to treat (ITT) analysis set
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	44 participants	43 participants	87 participants
		58.2 (9.22)	58.6 (8.38)	58.4 (8.77)
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	44 participants	43 participants	87 participants
Age group : <=55 years		15 34.1%	15 34.9%	30 34.5%
Age group : >55 years		29 65.9%	28 65.1%	57 65.5%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	44 participants	43 participants	87 participants
	Female	23 52.3%	23 53.5%	46 52.9%
	Male	21 47.7%	20 46.5%	41 47.1%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	44 participants	43 participants	87 participants
	White	41 93.2%	40 93.0%	81 93.1%
	Black or African American	1 2.3%	1 2.3%	2 2.3%
	Other	2 4.5%	2 4.7%	4 4.6%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	44 participants	43 participants	87 participants
Hispanic or Latino		7 15.9%	10 23.3%	17 19.5%
Not Hispanic or Latino		37 84.1%	33 76.7%	70 80.5%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	OS was calculated as the interval from the date of randomisation to th...
Description	OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive.
Time Frame	At least 12 months since start of treatment.

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Measure Type: Count of Participants Unit of Measure: Participants
Died	29 67.4%	27 67.5%
Alive at DCO	13 30.2%	13 32.5%
Withdrawn	1 2.3%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2069
	Comments	One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.
	Method	Regression, Cox
	Comments	Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 80% 0.56 to 1.14
	Estimation Comments	A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel

2.Secondary Outcome


Title	Progression Free Survival
Description	PFS was defined as the interval between the date of randomisation and ...
Description	PFS was defined as the interval between the date of randomisation and the earlier date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Patients who did not progress or die at the time of analysis were censored at the time of their latest evaluable objective tumour assessment. This also included patients who withdrew consent.
Time Frame	At least 12 months after start of treatment

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Measure Type: Count of Participants Unit of Measure: Participants
Progression	35 81.4%	36 90.0%
Prog. after >2 missed or non-eval. assessments	1 2.3%	2 5.0%
No progression	7 16.3%	2 5.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0138
	Comments	One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.
	Method	Regression, Cox
	Comments	The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 80% 0.42 to 0.79
	Estimation Comments	A Hazard Ratio (HR) < 1 favoured AZD6244 + Docetaxel

3.Secondary Outcome


Title	Objective Response Rate
Description	ORR is defined as the ratio of proportions, patients with at least one...
Description	ORR is defined as the ratio of proportions, patients with at least one visit response of CR or PR in AZD6244 + Docetaxel vs Placebo + Docetaxel.
Time Frame	At least 12 months after start of treatment

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Measure Type: Count of Participants Unit of Measure: Participants
Response	16 37.2%	0 0.0%
No response	27 62.8%	40 100.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	Two-sided P-value
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	37.2
	Confidence Interval	(2-Sided) 95% 23 to 53
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Duration of Response
Description	Duration of response is defined as the time from the date of first doc...
Description	Duration of response is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.
Time Frame	At least 12 months after start of treatment

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Mean (Standard Error) Unit of Measure: Days
	193.4 (0.207)	NA ^[1] (NA)

[1]

No instance of complete or partial response was recorded for this arm.

5.Secondary Outcome


Title	Change From Baseline in Tumour Size at 6 Week.
Description	Percentage change from baseline in tumour size at 6 week. Values calcu...
Description	Percentage change from baseline in tumour size at 6 week. Values calculated as tumour sizes at 6 weeks minus value at baseline.
Time Frame	6 weeks after first dose of treatment

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Least Squares Mean (80% Confidence Interval) Unit of Measure: Percentage change from baseline
	-16.98 (-27.1 to -6.85)	0.05 (-9.84 to 9.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.
	Method	ANCOVA
	Comments	LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.

Method of Estimation	Estimation Parameter	LSmeans difference
	Estimated Value	-17.03
	Confidence Interval	(2-Sided) 80% -25.2 to -8.86
	Estimation Comments	(AZD6244 + Docetaxel) - (Placebo + Docetaxel)

6.Secondary Outcome


Title	Change From Baseline in Tumour Size at Week 12
Description	Percentage change from baseline in tumour size at Week 12. Values calc...
Description	Percentage change from baseline in tumour size at Week 12. Values calculated as tumour sizes at 12 weeks minus value at baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Least Squares Mean (80% Confidence Interval) Unit of Measure: Percent change from baseline
	-19.38 (-34.7 to -4.09)	6.62 (-8.31 to 21.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.
	Method	ANCOVA
	Comments	LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-26.0
	Confidence Interval	(2-Sided) 80% -38.34 to -13.7
	Estimation Comments	(AZD6244 + Docetaxel) - (Placebo + Docetaxel)

7.Secondary Outcome


Title	Alive and Progression-Free at 6 Months
Description	Percentage of patients alive and progression-free at 6 months
Description	Percentage of patients alive and progression-free at 6 months
Time Frame	6 months after first dose of treatment

Outcome Measure Data

Analysis Population Description

MITT


Arm/Group Title	AZD6244 + Docetaxel	Placebo + Docetaxel
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/...	Placebo + Docetaxel 75 mg/m^2
Arm/Group Description:	AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Placebo + Docetaxel 75 mg/m^2
Overall Number of Participants Analyzed	43	40
Measure Type: Number Unit of Measure: percentage
	37.1	15.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD6244 + Docetaxel, Placebo + Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0158
	Comments	One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.
	Method	Log Rank
	Comments	Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 80% 0.37 to 0.78
	Estimation Comments	A hazard ratio (HR) <1 favours AZD6244 75 mg bd+Docetaxel

Adverse Events

Time Frame	Over a minimum period of 12 months since start of treatment, or the date of the final analysis of the data, whichever is the later
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	AZD6244 + Docetaxel		Placebo + Docetaxel
Arm/Group Description	AZD6244 75 mg bd + Docetaxel 75 mg/...		Placebo + Docetaxel 75 mg/m^2
Arm/Group Description	AZD6244 75 mg bd + Docetaxel 75 mg/m^2		Placebo + Docetaxel 75 mg/m^2
All-Cause Mortality
	AZD6244 + Docetaxel		Placebo + Docetaxel
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	AZD6244 + Docetaxel		Placebo + Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/44 (59.09%)		13/42 (30.95%)
Blood and lymphatic system disorders
Febrile neutropena ^† 1	6/44 (13.64%)	6	0/42 (0.00%)	0
Neutropena ^† 1	3/44 (6.82%)	3	3/42 (7.14%)	3
Cardiac disorders
Acute coronary syndrome ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Atrial flutter ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Cardiac arrest ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Pericardial effusion ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Sinus bradycardia ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Gastrointestinal disorders
Vomiting ^† 1	1/44 (2.27%)	1	1/42 (2.38%)	1
Abdominal pain ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Colitis ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Dyspepsia ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Gastric ulcer haemorrhage ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Retroperitoneal haematoma ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
General disorders
Face oedema ^† 1	2/44 (4.55%)	2	0/42 (0.00%)	0
Pyrexia ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Immune system disorders
Drug hypersensitivity ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Infections and infestations
Pneumonia ^† 1	4/44 (9.09%)	4	0/42 (0.00%)	0
Lower respiratory tract infection bacterial ^† 1	1/44 (2.27%)	1	1/42 (2.38%)	1
Cystitis ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Empyema ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Influenza ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Neutropenic infection ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Respiratory tract infection viral ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Sepsis ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Urinary tract infection ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Investigations
Blood creatine phosphokinase increased ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Creatinine renal clearance decreased ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Electrocardiogram t wave inversion ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Neutrophil count decreased ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/44 (0.00%)	0	2/42 (4.76%)	2
Pain in extremity ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Tumour pain ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Nervous system disorders
Syncope ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory failure ^† 1	3/44 (6.82%)	3	2/42 (4.76%)	2
Interstitial lung disease ^† 1	2/44 (4.55%)	2	0/42 (0.00%)	0
Pulmonary embolism ^† 1	2/44 (4.55%)	2	0/42 (0.00%)	0
Dyspnoea ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Dyspnoea exertional ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Pneumonitis ^† 1	0/44 (0.00%)	0	1/42 (2.38%)	1
Pneumothorax ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Pulmonary haemorrhage ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis acneiform ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
Psoriasis ^† 1	1/44 (2.27%)	1	0/42 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA version 14
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AZD6244 + Docetaxel		Placebo + Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/44 (97.73%)		42/42 (100.00%)
Blood and lymphatic system disorders
Neutropenia ^† 1	17/44 (38.64%)	17	15/42 (35.71%)	15
Anaemia ^† 1	7/44 (15.91%)	7	5/42 (11.90%)	5
Febrile neutropenia ^† 1	7/44 (15.91%)	7	0/42 (0.00%)	0
Eye disorders
Vision blurred ^† 1	6/44 (13.64%)	6	1/42 (2.38%)	1
Gastrointestinal disorders
Diarrhoea ^† 1	32/44 (72.73%)	32	7/42 (16.67%)	7
Nausea ^† 1	19/44 (43.18%)	19	12/42 (28.57%)	12
Vomiting ^† 1	19/44 (43.18%)	19	9/42 (21.43%)	9
Stomatitis ^† 1	16/44 (36.36%)	16	8/42 (19.05%)	8
Constipation ^† 1	14/44 (31.82%)	14	8/42 (19.05%)	8
Abdominal pain upper ^† 1	8/44 (18.18%)	8	4/42 (9.52%)	4
Dyspepsia ^† 1	8/44 (18.18%)	8	4/42 (9.52%)	4
Abdominal pain ^† 1	8/44 (18.18%)	8	1/42 (2.38%)	1
General disorders
Fatigue ^† 1	12/44 (27.27%)	12	14/42 (33.33%)	14
Asthenia ^† 1	31/44 (70.45%)	31	28/42 (66.67%)	28
Oedema peripheral ^† 1	18/44 (40.91%)	18	7/42 (16.67%)	7
Pyrexia ^† 1	12/44 (27.27%)	12	5/42 (11.90%)	5
Metabolism and nutrition disorders
Decreased appetite ^† 1	15/44 (34.09%)	15	11/42 (26.19%)	11
Dehydration ^† 1	5/44 (11.36%)	5	1/42 (2.38%)	1
Musculoskeletal and connective tissue disorders
Myalgia ^† 1	6/44 (13.64%)	6	7/42 (16.67%)	7
Musculoskeletal chest pain ^† 1	3/44 (6.82%)	3	8/42 (19.05%)	8
Arthralgia ^† 1	2/44 (4.55%)	2	8/42 (19.05%)	8
Back pain ^† 1	2/44 (4.55%)	2	6/42 (14.29%)	6
Nervous system disorders
Headache ^† 1	6/44 (13.64%)	6	5/42 (11.90%)	5
Dysgeusia ^† 1	5/44 (11.36%)	5	2/42 (4.76%)	2
Neuropathy peripheral ^† 1	5/44 (11.36%)	5	1/42 (2.38%)	1
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	10/44 (22.73%)	10	8/42 (19.05%)	8
Dysonoea exertional ^† 1	8/44 (18.18%)	8	10/42 (23.81%)	10
Dyspnoea ^† 1	5/44 (11.36%)	5	10/42 (23.81%)	10
Epistaxis ^† 1	7/44 (15.91%)	7	2/42 (4.76%)	2
Skin and subcutaneous tissue disorders
Alopecia ^† 1	13/44 (29.55%)	13	9/42 (21.43%)	9
Dermatitis acneiform ^† 1	17/44 (38.64%)	17	2/42 (4.76%)	2
Dry skin ^† 1	10/44 (22.73%)	10	4/42 (9.52%)	4
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA version 14

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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:	Tracy Cunningham
Organization:	AstraZeneca
Phone:	1-877-400-4656
EMail:	clinicaltrialtransparency@astrazeneca.com

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

Janne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crino L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.

Janne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crino L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00890825
Other Study ID Numbers:	D1532C00016
First Submitted:	April 29, 2009
First Posted:	April 30, 2009
Results First Submitted:	June 14, 2017
Results First Posted:	June 20, 2018
Last Update Posted:	June 20, 2018

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