A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00044512
Collaborator
(none)
137
23
1
66
6
0.1
Study Details
Study Description
Brief Summary
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
-
Pharmacokinetics (PK) profile of Sorafenib
-
Plasma and tissue tumor biomarkers
Study Design
Study Type:
Interventional
Actual Enrollment
:
137 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
Study Start Date
:
Aug 1, 2002
Actual Primary Completion Date
:
Feb 1, 2008
Actual Study Completion Date
:
Feb 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sorafenib 400 mg b.i.d. Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants for Each Type of Response [Until 30 days after termination of active therapy]
Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.
Secondary Outcome Measures
- Duration of Response [up to 3 years later]
Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
- Time to Response [up to 3 years later]
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
- Time to Progression [up to 3 years later]
Time from the first date of receiving study drug until the first documented PD.
- Duration of Stable Disease [up to 3 years later]
Time from the first day of receiving study drug until there was a documented PD or response.
- Time to Minor Response [up to 3 years later]
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
- Duration of Minor Response [Time from MR to PD]
Time from the date that MR was first documented to the date that PD was first documented.
- Overall Survival [Start of treatment to death]
Time from the first date of receiving study medication to death.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
-
Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
-
Measurable disease
-
At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
-
Presence of at least 1 of the following:
-
Alpha-fetoprotein greater than the upper limit of normal (ULN)
-
Hepatitis C antibody positive
-
Hepatitis B surface antigen positive
-
Child's Pugh class A or B
-
Candidate for systemic therapy
Exclusion Criteria:
-
Fibrolamellar disease mixed histology
-
Metastatic brain or meningeal tumors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles | California | United States | 90057 | |
| 2 | New York | New York | United States | 10021-6007 | |
| 3 | Bruxelles - Brussel | Belgium | 1000 | ||
| 4 | Bruxelles - Brussel | Belgium | 1070 | ||
| 5 | Bruxelles - Brussel | Belgium | 1090 | ||
| 6 | Gent | Belgium | 9000 | ||
| 7 | Leuven | Belgium | 3000 | ||
| 8 | Lille Cedex | France | 59020 | ||
| 9 | Marseille | France | 13005 | ||
| 10 | Paris | France | 75020 | ||
| 11 | Rennes Cedex | France | 35062 | ||
| 12 | Saint Herblain | France | 44805 | ||
| 13 | Haifa | Israel | 31096 | ||
| 14 | Jerusalem | Israel | 91120 | ||
| 15 | Petach Tikva | Israel | 49100 | ||
| 16 | Rehovot | Israel | 76100 | ||
| 17 | Tel Aviv | Israel | 64239 | ||
| 18 | Tel Hashomer | Israel | 52621 | ||
| 19 | Rozzano | Milano | Italy | 20089 | |
| 20 | Forlì | Italy | 47100 | ||
| 21 | Milano | Italy | 20122 | ||
| 22 | Pisa | Italy | 56126 | ||
| 23 | Verona | Italy | 37126 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00044512
Other Study ID Numbers:
- 10874
- NCT00048919
- NCT00058383
First Posted:
Sep 4, 2002
Last Update Posted:
Apr 16, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Bayer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Only subjects with measurable, histologically or cytologically documented hepatocellur carcinoma (HCC) which was inoperable or who had refused surgery could participate in this study. |
|---|---|
| Pre-assignment Detail | Of 147 enrolled patients, 137 received treatment. 10 patients failed screening; reasons were: target lesions identified at baseline (3), liver function tests too high for inclusion (2), prior systemic anticancer treatment (2), creatinine too high for inclusion (1), platelets too low for inclusion (1), diagnosis of HCC not confirmed (1) |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Period Title: Treatment | |
| STARTED | 137 |
| COMPLETED | 137 |
| NOT COMPLETED | 0 |
| Period Title: Treatment | |
| STARTED | 137 |
| COMPLETED | 135 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Overall Participants | 137 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
84
61.3%
|
| >=65 years |
53
38.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
40
29.2%
|
| Male |
97
70.8%
|
| Child Pugh Status (participants) [Number] | |
| Status A |
98
71.5%
|
| Status B |
38
27.7%
|
| Missing |
1
0.7%
|
| Eastern Cooperative Group performance status (ECOG PS) at study entry (participants) [Number] | |
| Grade 0 |
68
49.6%
|
| Grade 1 |
69
50.4%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Stage of Disease at study entry (TNM Classification) (participants) [Number] | |
| Stage 1 |
0
0%
|
| Stage 2 |
4
2.9%
|
| Stage 3 |
42
30.7%
|
| Stage 4 |
91
66.4%
|
Outcome Measures
| Title | Percentage of Participants for Each Type of Response |
|---|---|
| Description | Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria. |
| Time Frame | Until 30 days after termination of active therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age. |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 137 |
| Complete response (CR) |
0
0%
|
| Partial response (PR) |
2.2
1.6%
|
| Minor response (MR) |
5.8
4.2%
|
| Stable disease (SD) |
54.7
39.9%
|
| Progressive disease (PD) |
13.9
10.1%
|
| Not available for independent review (NA) |
22.6
16.5%
|
| Not evaluable (NE) |
0.7
0.5%
|
| Title | Duration of Response |
|---|---|
| Description | Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion. |
| Time Frame | up to 3 years later |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased. |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 3 |
| Median (Full Range) [days] |
374
|
| Title | Time to Response |
|---|---|
| Description | Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation). |
| Time Frame | up to 3 years later |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 3 |
| Median (95% Confidence Interval) [days] |
144
|
| Title | Time to Progression |
|---|---|
| Description | Time from the first date of receiving study drug until the first documented PD. |
| Time Frame | up to 3 years later |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 106 |
| Median (95% Confidence Interval) [days] |
167
|
| Title | Duration of Stable Disease |
|---|---|
| Description | Time from the first day of receiving study drug until there was a documented PD or response. |
| Time Frame | up to 3 years later |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 103 |
| Median (95% Confidence Interval) [days] |
166
|
| Title | Time to Minor Response |
|---|---|
| Description | Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression. |
| Time Frame | up to 3 years later |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 8 |
| Median (95% Confidence Interval) [days] |
84
|
| Title | Duration of Minor Response |
|---|---|
| Description | Time from the date that MR was first documented to the date that PD was first documented. |
| Time Frame | Time from MR to PD |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 8 |
| Mean (Full Range) [days] |
122
|
| Title | Overall Survival |
|---|---|
| Description | Time from the first date of receiving study medication to death. |
| Time Frame | Start of treatment to death |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). |
| Arm/Group Title | Sorafenib 400 mg b.i.d. |
|---|---|
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Measure Participants | 137 |
| Median (95% Confidence Interval) [days] |
280
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | Acronyms in Adverse Event section: Gastrointestinal (GI), Central Nervous System (CNS), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT), Acute Respiratory Distress Syndrome (ARDS), Without grade 3 or 4 (W/O GR 3 or 4), Neutropenia (Neu) | |
| Arm/Group Title | Sorafenib 400 mg b.i.d. | |
| Arm/Group Description | Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d."Other AE" section includes SAEs | |
All Cause Mortality |
||
| Sorafenib 400 mg b.i.d. | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Sorafenib 400 mg b.i.d. | ||
| Affected / at Risk (%) | # Events | |
| Total | 77/137 (56.2%) | |
| Blood and lymphatic system disorders | ||
| Neutrophils | 1/137 (0.7%) | |
| Hemoglobin | 6/137 (4.4%) | |
| Lymphopenia | 1/137 (0.7%) | |
| Platelets | 1/137 (0.7%) | |
| Lymphatics - Other (Specify) | 1/137 (0.7%) | |
| Cardiac disorders | ||
| Supraventricular Arrythmia, Sinus Bradicardia | 1/137 (0.7%) | |
| Supraventricular Arrythmia, Supraventricular Tachycardia | 2/137 (1.5%) | |
| Hypertension | 1/137 (0.7%) | |
| Cardiac Ischemia / Infarction | 1/137 (0.7%) | |
| Hypotension | 3/137 (2.2%) | |
| Cardiac General - Other (Specify) | 1/137 (0.7%) | |
| Eye disorders | ||
| Glaucoma | 1/137 (0.7%) | |
| Gastrointestinal disorders | ||
| Anorexia | 2/137 (1.5%) | |
| Ascites | 4/137 (2.9%) | |
| Dehydration | 2/137 (1.5%) | |
| Diarrhea | 1/137 (0.7%) | |
| Nausea | 2/137 (1.5%) | |
| GI - Other (Specify) | 1/137 (0.7%) | |
| Pancreatitis | 1/137 (0.7%) | |
| Proctitis | 1/137 (0.7%) | |
| Vomiting | 5/137 (3.6%) | |
| Hypoalbuminemia | 1/137 (0.7%) | |
| General disorders | ||
| Fever | 4/137 (2.9%) | |
| Fatigue | 9/137 (6.6%) | |
| Constitutional Symptoms - Other (Specify) | 4/137 (2.9%) | |
| Chest Pain | 3/137 (2.2%) | |
| Pain, Abdomen NOS | 3/137 (2.2%) | |
| Pain - Other (Specify) | 3/137 (2.2%) | |
| Hepatobiliary disorders | ||
| Alkaline Phospharase | 2/137 (1.5%) | |
| AST | 1/137 (0.7%) | |
| Hyperbilirubinemia | 8/137 (5.8%) | |
| Liver Dysfunction | 15/137 (10.9%) | |
| GGT increase | 1/137 (0.7%) | |
| Hepatobiliary - Other (Specify) | 20/137 (14.6%) | |
| Infections and infestations | ||
| Infection W/GR 3 or GR 4 Neu | 1/137 (0.7%) | |
| Infection without Neutropenia | 9/137 (6.6%) | |
| Infection - Other (Specify) | 1/137 (0.7%) | |
| Metabolism and nutrition disorders | ||
| Amylase | 1/137 (0.7%) | |
| Hyperkalemia | 2/137 (1.5%) | |
| Hypoglycemia | 1/137 (0.7%) | |
| Lipase | 1/137 (0.7%) | |
| Hypokalemia | 1/137 (0.7%) | |
| Hyponatremia | 1/137 (0.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal - Other (Specify) | 3/137 (2.2%) | |
| Nervous system disorders | ||
| CNS Ischemia | 1/137 (0.7%) | |
| Confusion | 4/137 (2.9%) | |
| Dizziness | 1/137 (0.7%) | |
| Memory Impairment | 1/137 (0.7%) | |
| Neurology - Other (Specify) | 1/137 (0.7%) | |
| Seizure | 1/137 (0.7%) | |
| Somnolence | 1/137 (0.7%) | |
| Syncope (Fainting) | 1/137 (0.7%) | |
| Renal and urinary disorders | ||
| Hypercreatininemia | 1/137 (0.7%) | |
| Renal Failure | 3/137 (2.2%) | |
| Genito-Urinary - Other | 1/137 (0.7%) | |
| Dysuria | 1/137 (0.7%) | |
| Urinary Retention | 2/137 (1.5%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| ARDS | 1/137 (0.7%) | |
| Cough | 1/137 (0.7%) | |
| Pleural Effusion | 3/137 (2.2%) | |
| Pulmonary - Other (Specify) | 3/137 (2.2%) | |
| Pneumonitis | 1/137 (0.7%) | |
| Dyspnea (Shortness of Breath) | 4/137 (2.9%) | |
| Skin and subcutaneous tissue disorders | ||
| Head-Foot Skin Reaction | 2/137 (1.5%) | |
| Wound Complication, non-infectious | 1/137 (0.7%) | |
| Dermatology - Other (Specify) | 1/137 (0.7%) | |
| Rash/Desquamation | 1/137 (0.7%) | |
| Vascular disorders | ||
| CNS Hemorrhage | 3/137 (2.2%) | |
| Melena / GI Bleeding | 2/137 (1.5%) | |
| Epistaxis | 1/137 (0.7%) | |
| Hemorrhage with Surgery | 1/137 (0.7%) | |
| Hemorrhage - Other (Specify) | 1/137 (0.7%) | |
| Rectal Bleeding | 2/137 (1.5%) | |
| Hematuria | 1/137 (0.7%) | |
| Hematemesis | 6/137 (4.4%) | |
| Hemorrhage / Bleeding W/O GR 3 or GR 4 Thrombo | 1/137 (0.7%) | |
Other (Not Including Serious) Adverse Events |
||
| Sorafenib 400 mg b.i.d. | ||
| Affected / at Risk (%) | # Events | |
| Total | 126/137 (92%) | |
| Blood and lymphatic system disorders | ||
| Hemoglobin | 14/137 (10.2%) | |
| Lymphopenia | 8/137 (5.8%) | |
| Platelets | 12/137 (8.8%) | |
| Cardiac disorders | ||
| Edema | 21/137 (15.3%) | |
| Hypertension | 10/137 (7.3%) | |
| Gastrointestinal disorders | ||
| Anorexia | 34/137 (24.8%) | |
| Diarrhea | 76/137 (55.5%) | |
| Nausea | 33/137 (24.1%) | |
| Ascites | 14/137 (10.2%) | |
| Constipation | 26/137 (19%) | |
| GI-Other | 21/137 (15.3%) | |
| Mucositis | 19/137 (13.9%) | |
| Vomiting | 26/137 (19%) | |
| General disorders | ||
| Fatigue | 76/137 (55.5%) | |
| Pain, Abdomen NOS | 49/137 (35.8%) | |
| Pain, Other | 32/137 (23.4%) | |
| Fever | 18/137 (13.1%) | |
| Weight Loss | 13/137 (9.5%) | |
| Pain, Head/Headache | 11/137 (8%) | |
| Pain, Muscle | 9/137 (6.6%) | |
| Hepatobiliary disorders | ||
| AST | 28/137 (20.4%) | |
| Bilirubin (Hyperbilirubinemia) | 40/137 (29.2%) | |
| Hypoalbuminemia | 7/137 (5.1%) | |
| Alkaline Phosphatase | 19/137 (13.9%) | |
| ALT | 20/137 (14.6%) | |
| GGT | 13/137 (9.5%) | |
| Hepatobiliary-Other | 8/137 (5.8%) | |
| Infections and infestations | ||
| Infection Without Neutropenia | 20/137 (14.6%) | |
| Metabolism and nutrition disorders | ||
| Amylase | 9/137 (6.6%) | |
| Hyperglycemia | 7/137 (5.1%) | |
| Lipase | 10/137 (7.3%) | |
| Metabolic/Lab-Other | 14/137 (10.2%) | |
| Nervous system disorders | ||
| Dizziness | 11/137 (8%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 15/137 (10.9%) | |
| Pulmonary-Other | 9/137 (6.6%) | |
| Dyspnea (Shortness of Breath) | 16/137 (11.7%) | |
| Voice Changes | 7/137 (5.1%) | |
| Skin and subcutaneous tissue disorders | ||
| Hand-Foot Skin Reaction | 42/137 (30.7%) | |
| Rash/Desquamation | 29/137 (21.2%) | |
| Alopecia | 16/137 (11.7%) | |
| Dermatology-Other | 12/137 (8.8%) | |
| Pruritus | 15/137 (10.9%) | |
Limitations/Caveats
Subjects had advanced disease and were heavily pretreated. National Cancer Institute-Common Toxicity Criteria (NCI-CTC) was translated to Medical Dictionary for Regulatory Activities (MedDRA) for System Organ Class (SOC) only.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Agreement between Sponsor and PI should be reached before publication
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00044512
Other Study ID Numbers:
- 10874
- NCT00048919
- NCT00058383
First Posted:
Sep 4, 2002
Last Update Posted:
Apr 16, 2014
Last Verified:
Mar 1, 2014