An Open Label Extension Study of the Efficacy of MORAb-003

• Sponsor: Morphotek (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01018563
• Collaborator: (none)
• Enrollment: 3
• Locations: 3
• Arm: 1
• Actual Duration (Months): 37.7
• Patient Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer	Drug: MORAb-003	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
• Actual Study Start Date: Jan 13, 2010
• Actual Primary Completion Date: Mar 5, 2013
• Actual Study Completion Date: Mar 5, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MORAb-003 Maintenance infusions of MORAb-003 every 3 weeks	Drug: MORAb-003; Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.; Other Names: Farletuzumab

Outcome Measures

Primary Outcome Measures

1. Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response [From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)]

   The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter [kU/L]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.

Secondary Outcome Measures

1. Progression-Free Survival (PFS) by GCIG [From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)]

   PFS was defined as the time from the date of first dose of study medication during the parent study MORAb-003-002 (NCT00318370) to the date of disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or to the date of death due to any cause in this study. PD per CA125 was defined as the first of 2 consecutive CA125 values >2*ULN (35 kU/L) on two occasions. Participants who were alive with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a participant received a non-study anticancer therapy or procedure, with censoring occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur.

2. Overall Survival (OS) [From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)]

   OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Participants who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date participant was last known to be alive.

3. Duration of Second Remission [From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)]

   The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: '(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4'. The length of second remission was censored at the date of study discontinuation if the participant did not receive any carboplatin/taxane therapy during this study. C = censored data.

4. Duration of Third Remission [From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)]

   The length of third remission (i.e., second remission in this study) was calculated using the following formula: '(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4'. The length of third remission was censored at the date of study discontinuation if the participant did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all participants.

Other Outcome Measures

1. Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria [From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)]

   Best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Participants were assigned to one of the following categories of change in disease status: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as CR in both target and non-target lesions with no new lesions. PR was defined as CR in target lesions and incomplete response or SD in non-target lesions with no new lesions, or PR in target lesions and non-PD in non-target lesions with no new lesions. SD was defined as SD in target lesions and non-PD in non-target lesions with no new lesions. PD was defined as PD in target lesions, any non-target lesions with either absence or presence of new lesions, or any target lesions, PD in non-target lesions with either absence or presence of new lesions, or any target or non-target lesions with new lesions.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Provision of Informed consent.

• Subjects must have been enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study.

• Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study.

• Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

Exclusion Criteria:

• Subjects that discontinued the MORAb-003-002 study for any reason.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Memorial Hospital	Chula Vista	California	United States	91911
2	South Texas Oncology & Hematology	San Antonio	Texas	United States	78229
3	Nationales Centrum fur Tumorerkrandungen	Heidelberg		Germany	69120

Sponsors and Collaborators

• Morphotek

Investigators

• Study Director: Susan Weil, MD, Morphotek

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morphotek
• ClinicalTrials.gov Identifier: NCT01018563
• Other Study ID Numbers: MORAb-003-002A; 2009-015825-36
• First Posted: Nov 23, 2009
• Last Update Posted: Dec 8, 2021
• Last Verified: Nov 1, 2015

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Morphotek: Extension study; Epithelial ovarian cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Farletuzumab

Study Results

Participant Flow

Recruitment Details	Participants participated and received single-agent farletuzumab maintenance therapy in MORAb-003-002 study (NCT00318370), achieved normalization of cancer antigen 125 levels and/or tumor assessment of complete/partial response(or stable disease and an investigator's assessment of a clinical benefit) after receiving farletuzumab plus chemotherapy to enter study.
Pre-assignment Detail	Study enrolled 3 participants who participated in the MORAb-003-002 study (NCT00318370), achieved a normalization of CA 125 levels and/or complete response or partial response after MORAb-003 in combination with standard chemotherapy, and received single-agent MORAb-003 maintenance therapy.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 milligram per meter square (mg/m^2), intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Period Title: Overall Study
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Farletuzumab- All Participants
Arm/Group Description	Participants received farletuzumab 62.5 or 100 mg/m^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to 37.7 months in this study.
Overall Participants	3
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58.0
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 66.7%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	1 33.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 33.3%
More than one race	0 0%
Unknown or Not Reported	2 66.7%

Outcome Measures

1. Primary Outcome

Title	Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
Description	The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter [kU/L]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.
Time Frame	From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
Measure Participants	2	1
Participant 1 (dose group: 62.5 mg/m^2)-C	77.2
Participant 2 (dose group: 62.5 mg/m^2)-C	73.3
Participant 3 (dose group: 100 mg/m^2)	18.0

2. Secondary Outcome

Title	Progression-Free Survival (PFS) by GCIG
Description	PFS was defined as the time from the date of first dose of study medication during the parent study MORAb-003-002 (NCT00318370) to the date of disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or to the date of death due to any cause in this study. PD per CA125 was defined as the first of 2 consecutive CA125 values >2*ULN (35 kU/L) on two occasions. Participants who were alive with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a participant received a non-study anticancer therapy or procedure, with censoring occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur.
Time Frame	From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Measure Participants	2	1
Participant 1 (dose group: 62.5 mg/m^2)-C: GCIG	77.8
Participant 2 (dose group: 62.5 mg/m^2)-C: GCIG	75.8
Participant 3 (dose group: 100 mg/m^2): GCIG	25.1

3. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Participants who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date participant was last known to be alive.
Time Frame	From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Measure Participants	2	1
Participant 1 (dose group: 62.5 mg/m^2)-C	78.3
Participant 2 (dose group: 62.5 mg/m^2)-C	76.7
Participant 3 (dose group: 100 mg/m^2)	59.5

4. Secondary Outcome

Title	Duration of Second Remission
Description	The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: '(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4'. The length of second remission was censored at the date of study discontinuation if the participant did not receive any carboplatin/taxane therapy during this study. C = censored data.
Time Frame	From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received chemotherapy plus farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.	Participants received chemotherapy plus farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Measure Participants	2	1
Participant 1 (dose group: 62.5 mg/m^2)	41.0
Participant 2 (dose group: 62.5 mg/m^2)-C	74.2
Participant 3 (dose group: 100 mg/m^2)	29.5

5. Secondary Outcome

Title	Duration of Third Remission
Description	The length of third remission (i.e., second remission in this study) was calculated using the following formula: '(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4'. The length of third remission was censored at the date of study discontinuation if the participant did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all participants.
Time Frame	From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled. Here "overall number of participants analyzed" are participants who were available for this outcome measure.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Measure Participants	1	1
Number [months]	37.3	25.0

6. Other Pre-specified Outcome

Title	Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
Description	Best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Participants were assigned to one of the following categories of change in disease status: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as CR in both target and non-target lesions with no new lesions. PR was defined as CR in target lesions and incomplete response or SD in non-target lesions with no new lesions, or PR in target lesions and non-PD in non-target lesions with no new lesions. SD was defined as SD in target lesions and non-PD in non-target lesions with no new lesions. PD was defined as PD in target lesions, any non-target lesions with either absence or presence of new lesions, or any target lesions, PD in non-target lesions with either absence or presence of new lesions, or any target or non-target lesions with new lesions.
Time Frame	From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all 3 participants who were enrolled.

Arm/Group Title	Farletuzumab 62.5 mg/m^2	Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.	Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
Measure Participants	2	1
CR	1 33.3%	1 NaN
SD	1 33.3%	0 NaN

Adverse Events

Time Frame	For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Adverse Event Reporting Description	Intention to treat population analysis set included all 3 participants who were enrolled.
Arm/Group Title	Farletuzumab 62.5 mg/m^2		Farletuzumab 100 mg/m^2
Arm/Group Description	Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.		Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
All Cause Mortality
	Farletuzumab 62.5 mg/m^2		Farletuzumab 100 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Farletuzumab 62.5 mg/m^2		Farletuzumab 100 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		1/1 (100%)
General disorders
Disease progression	0/2 (0%)	0	1/1 (100%)	1
Investigations
Neutrophil count decreased	1/2 (50%)	1	0/1 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/2 (50%)	1	0/1 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma	1/2 (50%)	1	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	Farletuzumab 62.5 mg/m^2		Farletuzumab 100 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/2 (50%)	1	0/1 (0%)	0
Leukopenia	1/2 (50%)	1	1/1 (100%)	1
Neutropenia	0/2 (0%)	0	1/1 (100%)	2
Thrombocytopenia	0/2 (0%)	0	1/1 (100%)	2
Eye disorders
Eyelid oedema	0/2 (0%)	0	1/1 (100%)	1
Gastrointestinal disorders
Diarrhoea	1/2 (50%)	2	1/1 (100%)	7
Nausea	1/2 (50%)	2	1/1 (100%)	3
Stomatitis	2/2 (100%)	2	0/1 (0%)	0
Abdominal distension	1/2 (50%)	1	1/1 (100%)	1
Abdominal pain	1/2 (50%)	1	0/1 (0%)	0
Colitis	1/2 (50%)	1	0/1 (0%)	0
Dry mouth	1/2 (50%)	1	0/1 (0%)	0
Dysphagia	1/2 (50%)	1	0/1 (0%)	0
Flatulence	0/2 (0%)	0	1/1 (100%)	3
Vomiting	1/2 (50%)	1	0/1 (0%)	0
General disorders
Fatigue	1/2 (50%)	2	1/1 (100%)	11
Asthenia	1/2 (50%)	1	0/1 (0%)	0
Local swelling	1/2 (50%)	1	0/1 (0%)	0
Oedema peripheral	0/2 (0%)	0	1/1 (100%)	4
Infections and infestations
Urinary tract infection	1/2 (50%)	1	1/1 (100%)	1
Fungal skin infection	0/2 (0%)	0	1/1 (100%)	1
Nasopharyngitis	0/2 (0%)	0	1/1 (100%)	3
Otitis media	0/2 (0%)	0	1/1 (100%)	1
Pharyngeal abscess	1/2 (50%)	1	0/1 (0%)	0
Tinea versicolour	0/2 (0%)	0	1/1 (100%)	1
Tooth infection	1/2 (50%)	1	0/1 (0%)	0
Injury, poisoning and procedural complications
Procedural pain	0/2 (0%)	0	1/1 (100%)	4
Traumatic haematoma	0/2 (0%)	0	1/1 (100%)	1
Investigations
Blood alkaline phosphatase increased	1/2 (50%)	2	0/1 (0%)	0
Haemoglobin decreased	1/2 (50%)	4	0/1 (0%)	0
Platelet count decreased	1/2 (50%)	2	0/1 (0%)	0
Red blood cell count decreased	1/2 (50%)	1	0/1 (0%)	0
White blood cell count decreased	1/2 (50%)	4	0/1 (0%)	0
Neutrophil count decreased	1/2 (50%)	1	0/1 (0%)	0
Metabolism and nutrition disorders
Hypophosphataemia	1/2 (50%)	2	1/1 (100%)	2
Decreased appetite	1/2 (50%)	1	0/1 (0%)	0
Hypokalaemia	1/2 (50%)	1	0/1 (0%)	0
Hypomagnesaemia	0/2 (0%)	0	1/1 (100%)	2
Vitamin B12 deficiency	0/2 (0%)	0	1/1 (100%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/2 (50%)	1	1/1 (100%)	2
Myalgia	1/2 (50%)	1	0/1 (0%)	0
Neck pain	1/2 (50%)	1	0/1 (0%)	0
Myosclerosis	0/2 (0%)	0	1/1 (100%)	1
Synovial Cyst	0/2 (0%)	0	1/1 (100%)	1
Muscle Spasms	0/2 (0%)	0	1/1 (100%)	1
Scoliosis	0/2 (0%)	0	1/1 (100%)	1
Nervous system disorders
Headache	1/2 (50%)	93	1/1 (100%)	2
Tremor	0/2 (0%)	0	1/1 (100%)	3
Psychiatric disorders
Anxiety	1/2 (50%)	1	1/1 (100%)	1
Depression	0/2 (0%)	0	1/1 (100%)	1
Panic Attack	0/2 (0%)	0	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/2 (0%)	0	1/1 (100%)	2
Dyspnoea	0/2 (0%)	0	1/1 (100%)	1
Nasal congestion	1/2 (50%)	1	0/1 (0%)	0
Obstructive Airways Disorder	0/2 (0%)	0	1/1 (100%)	1
Skin and subcutaneous tissue disorders
Pruritus	1/2 (50%)	1	1/1 (100%)	1
Pruritus allergic	1/2 (50%)	1	1/1 (100%)	1
Rash	1/2 (50%)	1	0/1 (0%)	0
Swelling face	1/2 (50%)	1	0/1 (0%)	0
Surgical and medical procedures
Tooth extraction	1/2 (50%)	1	0/1 (0%)	0
Vascular disorders
Hypertension	0/2 (0%)	0	1/1 (100%)	5
Hypotension	0/2 (0%)	0	1/1 (100%)	1

Limitations/Caveats

Study was terminated by sponsor due to futile results in the NCT00849667 (MORAb003-004) study.

More Information

Certain Agreements

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