Comparison of AZD6244 in combination with dacarbazine versus (vs) dacarbazine alone in BRAF mutation positive melanoma patients

Study identifier:D1532C00006

ClinicalTrials.gov identifier:NCT00936221

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Double-blind, Randomised study to assess the efficacy of AZD6244 in combination with dacarbazine compared with dacarbazine alone in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Medical condition

Melanoma

Phase

Phase 2

Healthy volunteers

Study drug

AZD6244, Dacarbazine, Placebo

Sex

All

Actual Enrollment

385

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Jul 2009

Primary Completion Date: 01 Nov 2011

Study Completion Date: 01 Nov 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Belo Horizonte, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Ijuí, Brazil

Location

Research Site

Sao Paulo, Brazil

Location

Research Site

Zürich, Switzerland

Location

Research Site

Novy Jicin, Czech Republic

Location

Research Site

Praha 2, Czech Republic

Location

Research Site

Brno, Czech Republic

Arms	Assigned Interventions
Active Comparator: 1 AZD6244 in combination with dacarbazine	Drug: AZD6244 oral capsules, 75mg twice daily Other Name: selumetinib Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC
Placebo Comparator: 2 Placebo in combination with dacarbazine	Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC Drug: Placebo Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
selumetinib 75mg BD +dacarbazine	selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine	Placebo twice daily + Dacarbazine

Participant Flow: Overall Study

	selumetinib 75mg BD +dacarbazine	Placebo BD + Dacarbazine
STARTED	45	46
Received Treatment	44	45
COMPLETED	44^[1]	45^[2]
NOT COMPLETED	1	1
Withdrawal by Subject	1	1

[1]	13 patients ongoing cutoff + 31 patients who had died.
[2]	10 patients ongoing at data cutoff + 35 patients who had died.

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
selumetinib 75mg BD +dacarbazine	selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine	Placebo twice daily + Dacarbazine

Baseline Measures

	selumetinib 75mg BD +dacarbazine	Placebo BD + Dacarbazine	Total
Number of Participants [units: Participants]	45	46	91
Age Continuous [units: Years] Mean ± Standard Deviation	55.7 ± 14.89	51.6 ± 16.21	53.6 ± 15.62
Gender, Male/Female [units: Participants]
Female	23	18	41
Male	22	28	50

Outcome Measures

1. Primary Outcome Measure: Overall Survival [ Time Frame: From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later ]

Measure Type	Primary
Measure Name	Overall Survival
Measure Description	Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.
Time Frame	From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT)

Reporting Groups

	Description
selumetinib 75mg BD + dacarbazine	selumetinib 75mg twice daily + dacarbazine
Placebo + dacarbazine	Matched Placebo + dacarbazine

Measured Values

	selumetinib 75mg BD + dacarbazine	Placebo + dacarbazine
Number of Participants Analyzed [units:participants]	45	46
Overall Survival [units: Days] Median (Full Range)	424 (63 to 760)	321 (66 to 739)

Statistical Analysis 1 for Overall Survival

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Cox
P-Value^[4]	0.3873
Hazard Ratio (HR)^[5]	0.93
80% Confidence Interval	( 0.67 to 1.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	1-sided p-value
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Progression free survival [ Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment ]

Measure Type	Secondary
Measure Name	Progression free survival
Measure Description	PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Time Frame	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT)

Reporting Groups

	Description
selumetinib 75mg BD + dacarbazine	selumetinib 75mg twice daily + dacarbazine
Placebo + dacarbazine	Matched Placebo + dacarbazine

Measured Values

	selumetinib 75mg BD + dacarbazine	Placebo + dacarbazine
Number of Participants Analyzed [units:participants]	45	46
Progression free survival [units: Days] Median (Full Range)	169 (37 to 596)	92 (32 to 660)

No statistical analysis provided for Progression free survival

3. Secondary Outcome Measure: Objective response rate [ Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment ]

Measure Type	Secondary
Measure Name	Objective response rate
Measure Description	ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR
Time Frame	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT)

Reporting Groups

	Description
selumetinib 75mg BD + dacarbazine	selumetinib 75mg twice daily + dacarbazine
Placebo + dacarbazine	Matched Placebo + dacarbazine

Measured Values

	selumetinib 75mg BD + dacarbazine	Placebo + dacarbazine
Number of Participants Analyzed [units:participants]	45	46
Objective response rate [units: Participants]
Response	18	12
Complete Response	1	1
Partial Response	17	11
Non-response	27	34
Stable Disease >=6 weeks	13	10
Progression	14	24

No statistical analysis provided for Objective response rate

4. Secondary Outcome Measure: Change in target lesion tumour size at week 12 [ Time Frame: randomization to week 12 ]

Measure Type	Secondary
Measure Name	Change in target lesion tumour size at week 12
Measure Description
Time Frame	randomization to week 12
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT)

Reporting Groups

	Description
selumetinib 75mg BD + dacarbazine	selumetinib 75mg twice daily + dacarbazine
Placebo + dacarbazine	Matched Placebo + dacarbazine

Measured Values

	selumetinib 75mg BD + dacarbazine	Placebo + dacarbazine
Number of Participants Analyzed [units:participants]	45	46
Change in target lesion tumour size at week 12 [units: % change] Median (Full Range)	-8.85 (-65.22 to 121.77)	0.22 (-72.50 to 295.79)

No statistical analysis provided for Change in target lesion tumour size at week 12

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
selumetinib 75mg BD +dacarbazine	selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine	Placebo twice daily + Dacarbazine

Serious Adverse Events

selumetinib 75mg BD +dacarbazine

Placebo BD + Dacarbazine

Total, serious adverse events

# participants affected / at risk

22/44 (50.00%)

8/45 (17.78%)

Infections and infestations

Erysipelas

# participants affected / at risk

2/44 (4.55%)

0/45 (0.00%)

Infections and infestations

Cellulitis

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Infections and infestations

Clostridium difficile colitis

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Infections and infestations

Device related infection

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Infections and infestations

Infection

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Infections and infestations

Lower respiratory tract infection

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Infections and infestations

Sepsis

# participants affected / at risk

1/44 (2.27%)

2/45 (4.44%)

Infections and infestations

Neutropenic sepsis

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Infections and infestations

Pneumonia

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Gastrointestinal disorders

Abdominal pain

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

Gastrointestinal disorders

Vomiting

# participants affected / at risk

2/44 (4.55%)

1/45 (2.22%)

Gastrointestinal disorders

Diarrhoea

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Gastrointestinal disorders

Constipation

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Blood and lymphatic system disorders

Disseminated intravascular coagulation

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Blood and lymphatic system disorders

Febrile neutropenia

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Blood and lymphatic system disorders

Neutropenia

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Blood and lymphatic system disorders

Thrombocytopenia

# participants affected / at risk

1/44 (2.27%)

1/45 (2.22%)

Blood and lymphatic system disorders

Anaemia

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

General disorders

Chest pain

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

General disorders

Pyrexia

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

General disorders

Asthenia

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

General disorders

Fatigue

# participants affected / at risk

0/44 (0.00%)

2/45 (4.44%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intracranial tumour haemorrhage

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

# participants affected / at risk

1/44 (2.27%)

1/45 (2.22%)

Vascular disorders

Arterial thrombosis limb

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Vascular disorders

Venous thrombosis limb

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Vascular disorders

Deep vein thrombosis

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Cardiac disorders

Left atrial dilatation

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Eye disorders

Periorbital oedema

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Eye disorders

Ocular hypertension

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Eye disorders

Retinal tear

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

Investigations

Alanine aminotransferase increased

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Investigations

Aspartate aminotransferase increased

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Musculoskeletal and connective tissue disorders

Groin Pain

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Nervous system disorders

Syncope

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Renal and urinary disorders

Renal colic

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Reproductive system and breast disorders

Prostatitis

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Skin and subcutaneous tissue disorders

Rash

# participants affected / at risk

1/44 (2.27%)

0/45 (0.00%)

Psychiatric disorders

Completed suicide

# participants affected / at risk

0/44 (0.00%)

1/45 (2.22%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
selumetinib 75mg BD +dacarbazine	selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine	Placebo twice daily + Dacarbazine

Other Adverse Events

selumetinib 75mg BD +dacarbazine

Placebo BD + Dacarbazine

Total, other (not including serious) adverse events

# participants affected / at risk

44/44 (100.00%)

44/45 (97.78%)

Blood and lymphatic system disorders

ANAEMIA

# participants affected / at risk

4/44 (9.09%)

2/45 (4.44%)

Blood and lymphatic system disorders

LEUKOPENIA

# participants affected / at risk

1/44 (2.27%)

3/45 (6.67%)

Blood and lymphatic system disorders

NEUTROPENIA

# participants affected / at risk

7/44 (15.91%)

7/45 (15.56%)

Blood and lymphatic system disorders

Thrombocytopenia

# participants affected / at risk

11/44 (25.00%)

6/45 (13.33%)

Eye disorders

EYELID OEDEMA

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

Eye disorders

PERIORBITAL OEDEMA

# participants affected / at risk

4/44 (9.09%)

1/45 (2.22%)

Gastrointestinal disorders

Abdominal Pain

# participants affected / at risk

9/44 (20.45%)

4/45 (8.89%)

Gastrointestinal disorders

Abdominal Pain Upper

# participants affected / at risk

4/44 (9.09%)

4/45 (8.89%)

Gastrointestinal disorders

Constipation

# participants affected / at risk

12/44 (27.27%)

13/45 (28.89%)

Gastrointestinal disorders

DIARRHOEA

# participants affected / at risk

21/44 (47.73%)

13/45 (28.89%)

Gastrointestinal disorders

DRY MOUTH

# participants affected / at risk

6/44 (13.64%)

0/45 (0.00%)

Gastrointestinal disorders

DYSPEPSIA

# participants affected / at risk

6/44 (13.64%)

2/45 (4.44%)

Gastrointestinal disorders

FLATULENCE

# participants affected / at risk

1/44 (2.27%)

5/45 (11.11%)

Gastrointestinal disorders

GASTROOESOPHAGEAL REFLUX DISEASE

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

Gastrointestinal disorders

NAUSEA

# participants affected / at risk

28/44 (63.64%)

25/45 (55.56%)

Gastrointestinal disorders

STOMATITIS

# participants affected / at risk

8/44 (18.18%)

5/45 (11.11%)

Gastrointestinal disorders

VOMITING

# participants affected / at risk

20/44 (45.45%)

14/45 (31.11%)

General disorders

ASTHENIA

# participants affected / at risk

12/44 (27.27%)

5/45 (11.11%)

General disorders

CHILLS

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

General disorders

FACE OEDEMA

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

General disorders

FATIGUE

# participants affected / at risk

16/44 (36.36%)

15/45 (33.33%)

General disorders

GENERALISED OEDEMA

# participants affected / at risk

6/44 (13.64%)

2/45 (4.44%)

General disorders

LOCALISED OEDEMA

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

General disorders

OEDEMA PERIPHERAL

# participants affected / at risk

19/44 (43.18%)

3/45 (6.67%)

General disorders

PYREXIA

# participants affected / at risk

5/44 (11.36%)

5/45 (11.11%)

Infections and infestations

FOLLICULITIS

# participants affected / at risk

5/44 (11.36%)

0/45 (0.00%)

Infections and infestations

NASOPHARYNGITIS

# participants affected / at risk

3/44 (6.82%)

6/45 (13.33%)

Infections and infestations

PARONYCHIA

# participants affected / at risk

6/44 (13.64%)

0/45 (0.00%)

Infections and infestations

RASH PUSTULAR

# participants affected / at risk

6/44 (13.64%)

0/45 (0.00%)

Infections and infestations

UPPER RESPIRATORY TRACT INFECTION

# participants affected / at risk

4/44 (9.09%)

2/45 (4.44%)

Infections and infestations

URINARY TRACT INFECTION

# participants affected / at risk

5/44 (11.36%)

0/45 (0.00%)

Investigations

ALANINE AMINOTRANSFERASE INCREASED^†

# participants affected / at risk

4/44 (9.09%)

3/45 (6.67%)

Investigations

ASPARTATE AMINOTRANSFERASE INCREASED

# participants affected / at risk

5/44 (11.36%)

1/45 (2.22%)

Investigations

BLOOD CREATININE PHOSPHOKINASE INCREASED

# participants affected / at risk

7/44 (15.91%)

0/45 (0.00%)

Investigations

BLOOD PRESSURE INCREASED

# participants affected / at risk

4/44 (9.09%)

0/45 (0.00%)

Investigations

WEIGHT INCREASED

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

Metabolism and nutrition disorders

DECREASED APPETITE

# participants affected / at risk

10/44 (22.73%)

11/45 (24.44%)

Metabolism and nutrition disorders

HYPOKALAEMIA

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

Musculoskeletal and connective tissue disorders

ARTHRALGIA

# participants affected / at risk

4/44 (9.09%)

3/45 (6.67%)

Musculoskeletal and connective tissue disorders

BACK PAIN

# participants affected / at risk

7/44 (15.91%)

3/45 (6.67%)

Musculoskeletal and connective tissue disorders

MYALGIA

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

Musculoskeletal and connective tissue disorders

PAIN IN EXTREMITY

# participants affected / at risk

3/44 (6.82%)

4/45 (8.89%)

Nervous system disorders

DIZZINESS

# participants affected / at risk

6/44 (13.64%)

2/45 (4.44%)

Nervous system disorders

DYSGEUSIA

# participants affected / at risk

4/44 (9.09%)

4/45 (8.89%)

Nervous system disorders

HEADACHE

# participants affected / at risk

5/44 (11.36%)

12/45 (26.67%)

Nervous system disorders

LETHARGY

# participants affected / at risk

2/44 (4.55%)

4/45 (8.89%)

Nervous system disorders

PARAESTHESIA

# participants affected / at risk

3/44 (6.82%)

4/45 (8.89%)

Nervous system disorders

SYNCOPE

# participants affected / at risk

4/44 (9.09%)

0/45 (0.00%)

Psychiatric disorders

ANXIETY

# participants affected / at risk

5/44 (11.36%)

5/45 (11.11%)

Psychiatric disorders

BRADYPHRENIA

# participants affected / at risk

0/44 (0.00%)

3/45 (6.67%)

Psychiatric disorders

DEPRESSION

# participants affected / at risk

3/44 (6.82%)

2/45 (4.44%)

Psychiatric disorders

INSOMNIA

# participants affected / at risk

3/44 (6.82%)

3/45 (6.67%)

Respiratory, thoracic and mediastinal disorders

COUGH

# participants affected / at risk

3/44 (6.82%)

4/45 (8.89%)

Respiratory, thoracic and mediastinal disorders

DYSPNOEA EXERTIONAL

# participants affected / at risk

8/44 (18.18%)

6/45 (13.33%)

Respiratory, thoracic and mediastinal disorders

EPISTAXIS

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

Respiratory, thoracic and mediastinal disorders

DYSPNOEA

# participants affected / at risk

3/44 (6.82%)

2/45 (4.44%)

Skin and subcutaneous tissue disorders

DERMATITIS ACNEIFORM

# participants affected / at risk

23/44 (52.27%)

1/45 (2.22%)

Skin and subcutaneous tissue disorders

DRY SKIN

# participants affected / at risk

10/44 (22.73%)

2/45 (4.44%)

Skin and subcutaneous tissue disorders

ECZEMA

# participants affected / at risk

5/44 (11.36%)

1/45 (2.22%)

Skin and subcutaneous tissue disorders

ERYTHEMA

# participants affected / at risk

4/44 (9.09%)

1/45 (2.22%)

Skin and subcutaneous tissue disorders

EXFOLIATIVE RASH

# participants affected / at risk

3/44 (6.82%)

1/45 (2.22%)

Skin and subcutaneous tissue disorders

HAIR COLOUR CHANGES

# participants affected / at risk

4/44 (9.09%)

0/45 (0.00%)

Skin and subcutaneous tissue disorders

NIGHT SWEATS

# participants affected / at risk

3/44 (6.82%)

4/45 (8.89%)

Skin and subcutaneous tissue disorders

PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME

# participants affected / at risk

5/44 (11.36%)

0/45 (0.00%)

Skin and subcutaneous tissue disorders

PRURITUS

# participants affected / at risk

3/44 (6.82%)

2/45 (4.44%)

Skin and subcutaneous tissue disorders

SKIN CHAPPED

# participants affected / at risk

4/44 (9.09%)

0/45 (0.00%)

Skin and subcutaneous tissue disorders

SKIN FISSURES

# participants affected / at risk

3/44 (6.82%)

0/45 (0.00%)

Vascular disorders

HYPERTENSION

# participants affected / at risk

8/44 (18.18%)

1/45 (2.22%)

Vascular disorders

LYMPHOEDEMA

# participants affected / at risk

11/44 (25.00%)

2/45 (4.44%)

Skin and subcutaneous tissue disorders

ALOPECIA

# participants affected / at risk

6/44 (13.64%)

2/45 (4.44%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gabriella Mariani
Organization:	AstraZeneca
Phone	+44 7818 523 899
E-mail:	[email protected]

Documents available

Cancer Study Locator (US and Canada only)
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D1532C00006.pdf
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Locator Service

877-400-4656

astrazeneca@emergingmed.com

Investigators

Principal Investigator

Mark Middleton

Churchil Hospital, Oxford, UK

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Cancer Study Locator (US and Canada only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=195&filename=CSP-D1532C00006.pdf

D1532C00006.pdf

Trial Results Summaries