Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• ClinicalTrials.gov Identifier: NCT00971932
• Recruitment Status: Completed
• First Posted: September 4, 2009
• Results First Posted: August 10, 2012
• Last Update Posted: April 8, 2014
• Sponsor: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): Merck KGaA, Darmstadt, Germany

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Drug: Cetuximab; Drug: Cisplatin/Carboplatin; Drug: 5-Fluorouracil
• Enrollment: 33

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Period Title: Overall Study
Started	33 [1]
Completed	26
Not Completed	7
Reason Not Completed
Withdrawal by Subject	1
Investigator's decision	2
Ongoing	4
[1] Number of participants treated.

Baseline Characteristics

Arm/Group Title		Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description		Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Baseline Participants		33
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	33 participants
		57.20 (11.42)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	33 participants
	Female	3 9.1%
	Male	30 90.9%

Outcome Measures

1. Primary Outcome

Title	Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
Description	Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
Time Frame	Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	36.4; (20.4 to 54.9)

2. Secondary Outcome

Title	Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Description	Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.
Time Frame	Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least one dose of the study medication.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	45.5; (28.1 to 63.6)

3. Secondary Outcome

Title	Disease Control Rate
Description	Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.
Time Frame	Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least one dose of the study medication.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	87.9; (71.8 to 96.6)

4. Secondary Outcome

Title	Duration of Response
Description	Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).
Time Frame	Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

Subgroup of participants from the study population with a best overall response (CR or PR).

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	12
Median (95% Confidence Interval); Unit of Measure: months
	2.8; (2.8 to 5.5)

5. Secondary Outcome

Title	Progression-Free Survival (PFS) Time
Description	The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.
Time Frame	Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least one dose of the study medication.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	33
Median (95% Confidence Interval); Unit of Measure: months
	4.1; (4.0 to 5.5)

6. Secondary Outcome

Title	Overall Survival (OS) Time
Description	Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time Frame	Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least one dose of the study medication.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	33
Median (95% Confidence Interval); Unit of Measure: months
	12.8 [1]; (8.7 to NA)

[1]

The upper limit of confidence interval (CI) for the median OS time was not estimated because no further events occurred after estimated median survival time of 12.8 months.

7. Secondary Outcome

Title	Time to Treatment Failure
Description	Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.
Time Frame	Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed "N" is signifying those participants for whom trial treatment failed.

Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description:	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Overall Number of Participants Analyzed	29
Median (95% Confidence Interval); Unit of Measure: months
	4.2; (4.1 to 5.6)

Adverse Events

Time Frame	Baseline until 30 days after last trial treatment.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
Arm/Group Title	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Arm/Group Description	Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
All-Cause Mortality
	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
	Affected / at Risk (%)
Total	12/33 (36.36%)
Cardiac disorders
Intracardiac mass * 1	1/33 (3.03%)
Gastrointestinal disorders
Diarrhea * 1	1/33 (3.03%)
Dysphagia * 1	1/33 (3.03%)
Mechanical ileus * 1	1/33 (3.03%)
Esophageal fistula * 1	1/33 (3.03%)
Infections and infestations
Septic shock * 1	1/33 (3.03%)
Staphylococcal sepsis * 1	1/33 (3.03%)
Investigations
C-reactive protein increased * 1	1/33 (3.03%)
Metabolism and nutrition disorders
Decreased appetite * 1	1/33 (3.03%)
Dehydration * 1	1/33 (3.03%)
Hypercreatininemia * 1	1/33 (3.03%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain * 1	1/33 (3.03%)
Nervous system disorders
Headache * 1	1/33 (3.03%)
Syncope * 1	1/33 (3.03%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
	Affected / at Risk (%)
Total	33/33 (100.00%)
Blood and lymphatic system disorders
Leukopenia * 1	28/33 (84.85%)
Neutropenia * 1	27/33 (81.82%)
Thrombocytopenia * 1	20/33 (60.61%)
Anemia * 1	16/33 (48.48%)
Lymphopenia * 1	11/33 (33.33%)
Leukocytosis * 1	4/33 (12.12%)
Neutrophilia * 1	2/33 (6.06%)
Cardiac disorders
Ventricular extrasystoles * 1	2/33 (6.06%)
Ear and labyrinth disorders
Tinnitus * 1	5/33 (15.15%)
Eye disorders
Ocular hyperemia * 1	2/33 (6.06%)
Gastrointestinal disorders
Stomatitis * 1	26/33 (78.79%)
Nausea * 1	23/33 (69.70%)
Constipation * 1	22/33 (66.67%)
Diarrhea * 1	16/33 (48.48%)
Vomiting * 1	12/33 (36.36%)
Cheilitis * 1	9/33 (27.27%)
Abdominal distension * 1	3/33 (9.09%)
Abdominal pain upper * 1	3/33 (9.09%)
Dysphagia * 1	3/33 (9.09%)
Dyspepsia * 1	2/33 (6.06%)
Abdominal discomfort * 1	2/33 (6.06%)
Anal hemorrhage * 1	2/33 (6.06%)
General disorders
Fatigue * 1	19/33 (57.58%)
Malaise * 1	7/33 (21.21%)
Injection site extravasation * 1	2/33 (6.06%)
Mucosal inflammation * 1	2/33 (6.06%)
Face edema * 1	2/33 (6.06%)
Chills * 1	2/33 (6.06%)
Infusion related reaction * 1	2/33 (6.06%)
Injection site swelling * 1	2/33 (6.06%)
Non-cardiac chest pain * 1	2/33 (6.06%)
Pyrexia * 1	7/33 (21.21%)
Hepatobiliary disorders
Hepatic function abnormal * 1	8/33 (24.24%)
Infections and infestations
Paronychia * 1	19/33 (57.58%)
Nasopharyngitis * 1	3/33 (9.09%)
Injury, poisoning and procedural complications
Fall * 1	2/33 (6.06%)
Investigations
Weight decreased * 1	16/33 (48.48%)
Hemoglobin decreased * 1	9/33 (27.27%)
Blood albumin decreased * 1	6/33 (18.18%)
Blood alkaline phosphatase increased * 1	6/33 (18.18%)
Protein total decreased * 1	6/33 (18.18%)
Weight increased * 1	5/33 (15.15%)
Blood lactate dehydrogenase increased * 1	3/33 (9.09%)
Blood creatinine increased * 1	3/33 (9.09%)
Alanine aminotransferase increased * 1	3/33 (9.09%)
Gamma-glutamyltransferase increased * 1	2/33 (6.06%)
Blood urea increased * 1	2/33 (6.06%)
Metabolism and nutrition disorders
Decreased appetite * 1	30/33 (90.91%)
Hypomagnesemia * 1	27/33 (81.82%)
Hyponatremia * 1	14/33 (42.42%)
Hypokalemia * 1	10/33 (30.30%)
Hypocalcemia * 1	8/33 (24.24%)
Hypochloremia * 1	6/33 (18.18%)
Hypoalbuminemia * 1	6/33 (18.18%)
Hyperkalemia * 1	5/33 (15.15%)
Hypercreatininemia * 1	5/33 (15.15%)
Musculoskeletal and connective tissue disorders
Back pain * 1	4/33 (12.12%)
Nervous system disorders
Dysgeusia * 1	11/33 (33.33%)
Headache * 1	5/33 (15.15%)
Neuropathy peripheral * 1	4/33 (12.12%)
Syncope * 1	2/33 (6.06%)
Psychiatric disorders
Insomnia * 1	6/33 (18.18%)
Anxiety * 1	2/33 (6.06%)
Renal and urinary disorders
Nephropathy toxic * 1	3/33 (9.09%)
Renal impairment * 1	2/33 (6.06%)
Respiratory, thoracic and mediastinal disorders
Hiccups * 1	13/33 (39.39%)
Epistaxis * 1	8/33 (24.24%)
Hemoptysis * 1	2/33 (6.06%)
Oropharyngeal pain * 1	2/33 (6.06%)
Pleural effusion * 1	2/33 (6.06%)
Skin and subcutaneous tissue disorders
Dry skin * 1	23/33 (69.70%)
Acne * 1	21/33 (63.64%)
Alopecia * 1	20/33 (60.61%)
Pruritus * 1	10/33 (30.30%)
Dermatitis acneiform * 1	7/33 (21.21%)
Rash generalized * 1	5/33 (15.15%)
Pruritus generalized * 1	5/33 (15.15%)
Skin fissures * 1	5/33 (15.15%)
Skin chapped * 1	4/33 (12.12%)
Rash * 1	4/33 (12.12%)
Pigmentation disorder * 1	2/33 (6.06%)
Vascular disorders
Orthostatic hypotension * 1	5/33 (15.15%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.0

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

• Name/Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA
• Phone: +49-6151-72-5200
• EMail: service@merckgroup.com

Publications of Results:

Yoshino T, Hasegawa Y, Takahashi S, Monden N, Homma A, Okami K, Onozawa Y, Fujii M, Taguchi T, de Blas B, Beier F, Tahara M. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10.

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT00971932
• Other Study ID Numbers: EMR 62241-056
• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Results First Submitted: July 4, 2012
• Results First Posted: August 10, 2012
• Last Update Posted: April 8, 2014